Découvrez ci-dessous la liste complète de nos communiqués de presse (page 14 sur 28) :
Greenwich LifeSciences expands Phase III breast cancer trial into Romania, partnering with top oncologist Dr. Nicoleta Antone.
Alto Neuroscience adds Dr. Raymond Sanchez to its Board, bringing 20+ years of CNS drug development and biotech leadership experience.
Tonix Pharmaceuticals’ Tonmya™, a first-in-class non-opioid therapy, wins U.S. FDA approval as a new treatment option for adults with fibromyalgia.
Novo Nordisk’s Wegovy® gains U.S. FDA approval for treating MASH in adults with liver fibrosis, expanding its use beyond obesity.
Explore Dr. Ashok Kumar Patra’s journey from research labs in Orissa to leadership in India’s biopharma sector. Learn how AI, biosimilars, and resilience shaped his vision for biologics.
HUTCHMED completes enrollment in SANOVO Phase III trial of ORPATHYS® + TAGRISSO® as first-line treatment for EGFR-mutated, MET+ NSCLC in China.
Madrigal’s Rezdiffra wins EC approval as first EU therapy for MASH with moderate to advanced fibrosis, offering new hope for liver disease patients.
SpyGlass Pharma names Elizabeth O’Farrell as Independent Director & Audit Chair, adding 30+ years of pharma and biotech leadership expertise.
MMS collaborates with Friends of Cancer Research to develop decision frameworks for interpreting interim overall survival (OS) data in oncology trials.
Alvotech appoints Patrik Ling as VP Investor Relations Scandinavia, leveraging his 25+ years of life-science and equity analyst experience.
Aligos Therapeutics announces the appointment of Dr. Ramón Polo, PharmD, PhD, MBA, as Senior VP, Head of Global Regulatory Affairs, to lead regulatory strategies for ALG-000184.
PharmaTech & LabTech Expo 2025 concludes with 400+ exhibitors, 22K+ visitors, and major innovations in pharma and lab technology.
Crinetics Pharmaceuticals secures FDA Orphan Drug Designation for atumelnant, a novel ACTH receptor antagonist in development for congenital adrenal hyperplasia.
Parexel appoints Jim Anthony as Chief Commercial Officer and President of Biotech to drive growth, customer focus, and advance life sciences solutions.
The European Commission approves Mynzepli®, Alvotech’s biosimilar to Eylea®, for retinal diseases, key steps in expanding access to vision care in Europe.
PathAI and Moffitt Cancer Center team up to deploy AISight® Dx digital pathology platform, driving innovation and precision in cancer detection and research.
Krystal Biotech updates oncology program, advancing inhaled KB707 for non-small cell lung cancer with promising efficacy and FDA engagement.
AbbVie’s Phase 3 UP-AA program shows RINVOQ® helps restore scalp, eyebrow, and eyelash hair in severe alopecia areata, with a consistent safety profile.
Thermo Fisher launches a 375,000-sq-ft carbon-neutral site in Mebane, N.C., producing 40M pipette tips weekly to power U.S. medicine and diagnostics.
HUTCHMED appoints CFO Johnny Cheng as Acting CEO after Dr. Weiguo Su takes medical leave, ensuring leadership continuity and strategic progress.
Argent BioPharma’s ArtemiC™ achieved 85% survival in a severe viral ARDS study, reducing viral load and cytokine-driven inflammation.
FDA suspends Valneva’s IXCHIQ® license after four new adverse events. The company is investigating cases while assessing financial impact.
Eisai & Biogen launch LEQEMBI® in Austria & Germany, the first EU therapy targeting amyloid plaques and protofibrils in early Alzheimer’s disease.
Terumo infusion pump range Terufusion launches in India. What the range includes, the hospital segments it targets, and how it fits India's infusion market.
Immuneering signs clinical supply deal with Eli Lilly to study atebimetinib plus olomorasib in Phase 2 trial for KRAS G12C-mutant NSCLC patients.
Oculis appoints neuro-ophthalmology pioneer Dr. Mark Kupersmith and retina specialist Dr. Sebastian Wolf as Chief Medical Advisors to advance innovation.
Grace Therapeutics’ NDA for GTx-104, an IV nimodipine for aSAH, has been accepted by the FDA with a PDUFA target date of April 23, 2026.
Eli Lilly’s Verzenio plus endocrine therapy showed significant OS, IDFS, and DRFS benefits in the Phase 3 monarchE trial for high-risk early breast cancer.
Santhera signs a 5-year deal with Ikris to distribute AGAMREE for Duchenne muscular dystrophy in India, starting 2025 for patients aged 4 and older.
Outlook Therapeutics receives FDA CRL for ONS-5010 in wet AMD due to efficacy concerns, while expanding LYTENAVA™ commercialization in Europe.
Thermo Fisher earns R&D 100 Awards for its Stellar MS, PlasmidPro, and SteriSEQ products, advancing precision medicine, cell therapy, and biopharma research.
Eagle Pharmaceuticals appoints Abhinav Jain to its Board as part of an agreement with Nantahala Capital, with plans for a second new director by May 2026.
Sandoz launches generic rivaroxaban 10, 15, and 20 mg in Germany, expanding access after a key patent win and joining discount agreements to boost affordability.
FDA approves Sanofi’s Wayrilz (rilzabrutinib), the first BTK inhibitor for adults with immune thrombocytopenia unresponsive to prior treatments
Rotzinger PharmaPack unveils VarioFill, a compact, modular filling and capping platform for OTC pharma, cosmetics, and nutraceuticals—offering 50% space savings and rapid product changeovers.
Merck’s VERQUVO did not meet its primary endpoint in the VICTOR trial for stable HFrEF, but pooled data with VICTORIA showed significant benefit across patients.
Novo Nordisk’s STEER study shows Wegovy® lowers risk of heart attack, stroke, or death by 57% vs tirzepatide in obese patients with heart disease.
Novartis’ V-DIFFERENCE study shows Leqvio® enables early LDL-C goal achievement with 43% lower muscle pain risk, improving outcomes in high cholesterol patients.
Roche and Alnylam launch global Phase III ZENITH trial to test zilebesiran in 11,000 patients with uncontrolled hypertension for cardiovascular outcomes.
ELMACH unveils the EPI-3015 PDA, a modular blister machine with 100% inspection, servo precision, and tool-less changeovers for pharma, nutra, and personal care.
OMass inks $20M deal with Genentech to develop and commercialize new oral therapies for inflammatory bowel disease, with milestones over $400M.
FibroGen completes $220M sale of China subsidiary to AstraZeneca, repays debt, and extends cash runway into 2028 to support key clinical milestones
Jade Biosciences dose first cohort in Phase 1 trial of JADE101, a novel anti-APRIL antibody aiming to treat IgA nephropathy by targeting APRIL.
Maze Therapeutics appoints Misbah Tahir as CFO, adding 20+ years of biopharma financial leadership and $1B fundraising success at IGM Biosciences.
Step Pharma doses first participant in Phase 1b trial of dencatistat for essential thrombocythaemia, advancing CTPS1 inhibition for safer targeted therapies.
Opus Genetics names Rob Gagnon, CPA, MBA, CFO to drive financial strategy and growth in gene therapy and ophthalmic drug development.
Candel Therapeutics appoints immunotherapy pioneer Dr. Carl H. June to its Research Advisory Board to advance viral immunotherapy programs for cancer.
NMD Pharma names Dr. Ana de Vera as CMO to lead development of neuromuscular disease therapies, including Phase 2 trials of lead candidate NMD670.
Sanara MedTech appoints Seth Yon as President & CEO effective Sept 15, 2025, succeeding Ron Nixon, who remains Executive Chairman.
Vaxart announces Chairman Michael J. Finney’s retirement, marking his impactful leadership in advancing oral pill vaccine programs.
Valneva reports strong Phase 2 booster data for Lyme vaccine VLA15 with 100% seroconversion and favorable safety across all age groups.
Eisai and Biogen begin FDA rolling submission for LEQEMBI IQLIK, a weekly SC autoinjector offering a convenient home-use option for early Alzheimer’s treatment.
Outlook Therapeutics submits FDA Type A meeting request to discuss CRL on ONS-5010, seeking clarity on confirmatory evidence for U.S. approval.
Thermo Fisher acquires Sanofi’s Ridgefield, NJ facility, expanding U.S. sterile fill-finish capacity and strengthening its CDMO and CRO Accelerator™ platform.
Thermo Fisher completes $4B acquisition of Solventum’s Purification & Filtration business, expanding bioproduction and industrial filtration capabilities.
Vor Bio appoints Adi Osovsky, S.J.D., as General Counsel, bringing 17 years of biotech legal and compliance expertise to support company growth.
Medicus Pharma acquires Antev, gaining rights to Teverelix for prostate cancer and AURr. Adds $6B market potential and new board members in strategic expansion.
Join 800+ global experts at Cell & Gene Therapy International 2025 in Boston from Sept 16–18. Explore manufacturing, analytics, CDMO partnerships, AI, and more. Register now.
LIXTE adds new board members, appoints CFO, and relocates HQ to Florida, strengthening its mission to advance innovative cancer therapies.
Achieve Life Sciences’ NDA for cytisinicline to aid adult smoking cessation accepted by FDA, with a PDUFA target action date of June 20, 2026.
Adagene welcomes Dr. Axel Hoos, oncology leader and immunotherapy pioneer, as Executive Advisor to guide its antibody-based cancer therapy pipeline.
Artelo Biosciences reports positive Phase 2 CAReS results for ART27.13 in cancer anorexia-cachexia, boosting plans to secure a development partner.
Perspective Therapeutics appoints GSK U.S. Commercial President Maya Martinez-Davis as independent director, bringing oncology and pharma leadership expertise.
Charles River integrates Akadeum’s GMP-grade T cell isolation kit into its Cell Therapy Flex Platform, boosting cell viability and streamlining CAR-T development.
Allergan Aesthetics launches “Naturally You” campaign with providers and influencers to educate on safe, natural-looking outcomes of HA injectable fillers.
Silo Pharma has been granted an Australian patent for SPC-15, an intranasal therapy targeting PTSD, enhancing its global intellectual property portfolio.
AbbVie’s Phase 2 trial shows epcoritamab can be safely dosed outpatient in R/R DLBCL, with strong response rates in earlier treatment lines.
Autonomix’s first-in-human trial shows rapid, lasting pain relief in pancreatic cancer patients, with responders opioid-free at three months.
Roche’s Contivue® with Susvimo earns EU CE mark, showing sustained vision outcomes in nAMD with fewer treatments and strong long-term durability.
Explore Borosil Scientific’s lab solutions at analytica Anacon India 2025, Booth H4-B41, from glassware to LabQuest instruments and packaging.
Hinge Bio adds biotech leaders to advance GEM-DIMER™ programs and shares HB2198 preclinical proof in Scientific Reports for autoimmune diseases.
Walden Biosciences boosts its Phase 2 study of WAL0921 for rare kidney diseases with expert regulatory guidance and a NephCure patient partnership.
Arcutis files sNDA with FDA to expand ZORYVE® cream 0.3% use for plaque psoriasis in children ages 2–5, aiming to provide the first non-steroidal option.
Longeveron names Than Powell interim CEO and Dr. Joshua Hare Executive Chairman as the company advances pivotal stem cell therapy trials.
Agios announces FDA extended PYRUKYND sNDA review to Dec 7, 2025, after REMS submission to address hepatocellular injury risk in thalassemia patients.
Oncotelic shares pipeline updates and honors CEO Dr. Vuong Trieu, whose inventions include Abraxane® and Cynviloq™, shaping oncology and rare disease innovation.
Indaptus updates its INDP-D101 trial, showcasing its Decoy platform’s potential in cancer and viral diseases through multi-pathway immune activation.
Amneal gains FDA approval for risperidone ER injectable, with 180-day exclusivity and Q4 2025 launch, targeting schizophrenia and bipolar I disorder.
Roche reports new Vabysmo® data: sustained 4-year outcomes in nAMD and vision gains with lesion resolution in PCV, confirming durability and safety.
Join Agilent’s free webinar on Sept 17 to master polar compound analysis using HILIC, SPP, and reverse-phase columns. Reserve your seat now!
Sionna Therapeutics names Caroline Stark Beer CBO to lead business strategy, partnerships, and corporate development, advancing therapies for cystic fibrosis.
Moleculin begins EU dosing in Phase 3 MIRACLE trial evaluating Annamycin plus cytarabine for relapsed/refractory AML, targeting fast-track approval.
ElevateBio appoints Larry Lockwood, Ph.D., as CCO to drive commercial strategy, expand BaseCamp partnerships, and boost genetic medicine growth.
CHARM Therapeutics appoints Dr. Erkut Bahceci as CMO to lead clinical strategy for its next-gen menin inhibitor, targeting AML trials starting in 2026.
BioNTech & BMS share Phase 2 results of pumitamig in ES-SCLC, showing strong tumor responses, early PFS benefit, and manageable safety profile.
I-Mab boosts investment in givastomig, plans Phase 2 trial in 2026 with Phase 1b data readout early 2026, and announces key leadership changes
Lexicon shares new clinical data with FDA to support Zynquista resubmission, highlighting benefit-risk profile as adjunct therapy in type 1 diabetes.
Telix will resubmit NDA for glioma imaging agent TLX101-CDx in Q4 2025 after FDA guidance, with expedited review likely.
Phase 2 data show ANKTIVA reverses lymphopenia in NSCLC, significantly prolonging survival in patients resistant to checkpoint inhibitors.
Real-world data show ARS Pharma’s neffy nasal spray successfully treats 89% of anaphylaxis cases, matching epinephrine injection efficacy.
BioAtla announces FDA-guided pivotal trial for ozuriftamab vedotin in HPV+ OPSCC, targeting accelerated approval via ORR and full approval with OS benefit.
Medicus Pharma launches Phase 2 trial for non-invasive BCC therapy in the UAE, expands U.S./EU studies, signs HelixNano MoU, and acquires Antev for Teverelix.
Regeneron reports Phase 3 success for investigational allergen-blocking antibodies in cat and birch allergies, meeting primary and secondary endpoints.
NKGen Biotech acquires NKMax, gaining full control of its manufacturing, IP, and commercialization rights to expand NK cell therapy capabilities.
Teva’s emrusolmin receives FDA Fast Track for treating rare neurodegenerative disorder Multiple System Atrophy, accelerating its Phase 2 development.
Capricor addresses FDA’s public CRL for Deramiocel, its DMD cell therapy, and outlines plans to resolve issues and advance regulatory approval.
Silo Pharma secures Japan patent for SPC-15, licensed from Columbia University, strengthening its global IP portfolio for PTSD treatment.
Numab appoints Barbara Angehrn Pavik as CEO and Board member, succeeding co-founder David Urech, who transitions to Chair of the R&D Committee
Novartis plans to acquire Tourmaline Bio, adding pacibekitug, an IL-6 antibody for ASCVD, to strengthen its cardiovascular pipeline.
Amneal secures FDA approval and 180-day CGT exclusivity for risperidone extended-release injectable suspension in four strengths.
Sandoz resolved Regeneron’s patent dispute, paving the way for U.S. launch of its FDA-approved Eylea® biosimilar Enzeevu™ as early as Q4 2026.
Regeneron’s Libtayo plus chemotherapy improved survival in advanced NSCLC, with a 34% lower death risk and nearly double five-year survival rates.
Xilio advances tumour-activated IL-12 therapy XTX301 into Phase 2 for advanced solid tumours, earning $17.5M from Gilead, with cash runway into 2027.
Jazz’s Modeyso™ (dordaviprone) gains NCCN guideline inclusion as a treatment for recurrent H3 K27M-mutant glioma, following FDA accelerated approval.
HCW Biologics develops second-gen T-cell engagers targeting tissue factor and mesothelin in solid tumours, showing strong preclinical efficacy and safety.
Elutia to sell EluPro™ and CanGaroo® bioenvelopes to Boston Scientific for $88M, eliminating debt and funding its drug-eluting breast reconstruction pipeline.
Join 63,000+ professionals at CPHI Frankfurt 2025, the world’s largest pharma event, featuring 2,000+ exhibitors, new zones, and global networking.
Greenwich LifeSciences earns FDA Fast Track for GLSI-100 in HLA-A*02 HER2+ breast cancer, enabling rolling review and potentially earlier approval.
Artelo Biosciences reports preclinical data showing ART12.11 surpasses CBD in efficacy and bioavailability, advancing toward human studies in 2026.
Design Therapeutics appoints Justin Gover, ex-CEO of GW Pharma, to its Board as Arsani William steps down after guiding IPO and pipeline progress.
Kane Biotech surpasses enrollment goals with 28 participants in U.S. case series of its FDA-cleared revyve® Antimicrobial Wound Gel and Spray.
LIXTE Biotechnology buys $2.6M in Bitcoin and Ethereum, now holding 43.6% of its treasury in crypto while advancing its cancer drug pipeline.
Trethera finishes Phase 1 enrollment for TRE-515, a dCK inhibitor showing safety and early antitumor activity in advanced solid tumors.
FDA grants fast track to Sanofi’s SAR402663 gene therapy for neovascular AMD, aiming to speed development and improve treatment for wet AMD patients.
Merck reports positive Phase 3 STRIDE-13 results for CAPVAXIVE®, showing immune protection in high-risk children and adolescents against pneumococcal disease.
Amneal secures FDA approval for its sodium oxybate oral solution, expanding access to a standard of care therapy for narcolepsy patients.
Charles River announces alliances with PICI and CHLA, expanding its oncology CDMO role with preclinical services and support for pediatric cancer research.
Achieve Life Sciences names Dr. Mark Rubinstein as Interim CMO, succeeding Dr. Cindy Jacobs, to advance cytisinicline for smoking cessation.
Nacuity’s NPI-001 slows photoreceptor loss in Usher syndrome-related retinitis pigmentosa, showing strong Phase 1/2 trial results and safety profile.
Immix Biopharma names ex-Tanox CEO Nancy T. Chang to its board after her Goose Capital investment, strengthening its cell therapy expertise.
OSE and FoRT finish enrolling 105 patients for Combi-TED Phase 2 testing Tedopi® with nivolumab or docetaxel in advanced NSCLC. Results due 2026.
GRI Bio reports six-week Phase 2a results for GRI-0621 in IPF, showing stable lung function, anti-fibrotic biomarker trends, and continued trial progress.
Join Pharma Now × Pharmig UK for a free webinar on Annex 1 and microbiological compliance in India. Live on Sept 23, 2025. Register now for FREE!
Thermo Fisher introduces Olink® Target 48 Neurodegeneration panel, enabling absolute quantification of 41 biomarkers to drive precision research in neurology.
aTyr Pharma's Phase 3 EFZO-FIT™ trial of efzofitimod in pulmonary sarcoidosis missed its primary endpoint but demonstrated improved quality of life and steroid reduction.
Thermo Fisher introduces Gibco™ Efficient-Pro™ Medium (+) Insulin, AOF formulation, and simplified workflows for CHO-based biologics.
Raludotatug deruxtecan (R-DXd), Daiichi Sankyo and Merck’s CDH6-targeting ADC, earns FDA Breakthrough Therapy Designation in platinum-resistant ovarian cancer.
Monte Rosa and Novartis expand partnership with $120M upfront and up to $5.7B in milestones to advance molecular glue degraders for immune-mediated diseases.
Perspective Therapeutics doses first patient in Phase 1/2a [212Pb]VMT01 + Opdivo melanoma trial, aiming to improve survival for patients with metastatic disease.
Ocugen signs deal with Kwangdong for exclusive Korean rights to OCU400, with $7.5M upfront, milestones, 25% royalties, and plans for 2026 BLA filing.
EMA approves Rybelsus update highlighting cardiovascular benefits from the SOUL trial in type 2 diabetes.
Spyre starts Phase 2 SKYWAY trial of SPY072 for RA, PsA & axSpA, aiming for long-lasting, low-dose rheumatic therapies.
Atavistik Bio appoints Dr. Susan Pandya as CMO to guide ATV-1601 trials and advance its precision allosteric therapeutics pipeline.
Biocartis’ Idylla CDx MSI Test earns FDA PMA to guide OPDIVO and YERVOY use in MSI-H colorectal cancer patients.
Krystal Biotech’s VYJUVEK label now lets DEB patients of any age apply treatment at home with easier wound care flexibility.
SpyGlass names Anand Sundaram VP & Head of Commercial to lead launch strategy for its late-stage ophthalmic drug delivery platform.
Corbus’ CRB-701 earns FDA Fast Track for recurrent or metastatic HNSCC after chemo and PD-(L)1 therapy.
Parexel names Rob Goodwin COO to enhance clinical operations and drive excellence in global research solutions.
Oryzon secures new AU & EU patents for LSD1 inhibitors, boosting IP for oncology and CNS therapies.
Adagene amends deal with Exelixis to develop a masked ADC using its SAFEbody tech, targeting solid tumors with improved safety.
AstraZeneca’s Saphnelo met the primary endpoint in the Phase III TULIP-SC trial, showing disease reduction in lupus patients with a consistent safety profile.
Nxera Pharma and Cancer Research UK announce first patient dosed in Phase 2a trial of HTL0039732, a novel EP4 antagonist for advanced solid tumours.
Theratechnologies secures final court approval for its arrangement with Future Pak affiliate CB Biotechnology, with closing expected by September 25, 2025.
Baxter introduces the FDA-cleared Welch Allyn Connex 360 Vital Signs Monitor, designed to boost clinical efficiency, security, and patient data accuracy.
Takeda will be the first pharma company to transport medicines between Europe and the U.S. using VELA’s wind-powered sailing cargo trimarans, debuting in 2026.
AstraZeneca announced topline results from the Phase III RESOLUTE trial of Fasenra in COPD, study missed its primary endpoint but maintained safety profile.
Neuronetics announces New York State Medicaid will cover NeuroStar® TMS for major depressive disorder beginning Oct. 2025, expanding access to patients.
Biogen announces EU approval of ZURZUVAE®, the first treatment for post-partum depression, offering a novel 14-day oral therapy for mothers across Europe.
Roche announces agreement to acquire 89bio, expanding its CVRM pipeline with pegozafermin, a late-stage therapy for MASH and advanced liver fibrosis.
Eli Lilly’s SURPASS-PEDS trial shows Mounjaro® significantly improves A1C and BMI in children and adolescents with type 2 diabetes.
Eli Lilly’s ACHIEVE-3 trial shows orforglipron delivers greater A1C and weight loss benefits than oral semaglutide in type 2 diabetes patients.
Akari Therapeutics files patent for PH1 spliceosome payload ADC platform to advance innovative cancer treatments and improve outcomes.
Mumbai Biocluster launches PCG 2025, uniting global leaders to shape the future of peptides and complex generics on Sept 25–26.
ADARx names industry veteran Laura Shawver, Ph.D., as Board Chair to strengthen leadership and guide growth in RNA therapeutics development.
Invivyd appoints communications expert Kristie Kuhl as CCO to lead strategy and advocacy, strengthening its mission to combat viral diseases.
Palisade Bio’s PALI-2108 shows rapid clinical activity and safety in Phase 1b UC study, supporting its potential as a targeted anti-inflammatory and anti-fibrotic therapy.
Tonix secures global rights to TNX-4800, a Phase 2/3-ready monoclonal antibody offering single-dose, seasonal protection against Lyme disease.
Informa Markets unveils the finalists for the CPHI Pharma Awards 2025, celebrating innovation, sustainability, leadership, and women shaping the future of pharma.
Eight Roads Ventures hosts Scale-Up Health 2025, spotlighting biotech, AI, and value-based care as India enters a decade of healthcare transformation.
Vaxart names veteran CPA and ex-Deloitte executive W. Mark Watson as lead independent director to guide its innovative oral vaccine platform.
Labindia’s 1Labinfra unveils a Ductless Fume Hood with HEPA & multi-filter tech at Analytica India 2025, boosting lab safety & energy efficiency.
Epitopea appoints four renowned cancer immunology experts to its advisory board to advance RNA-based cancer immunotherapies.
Tonix reports positive FDA Pre-IND meeting on TNX-102 SL, advancing plans to develop a new treatment option for major depressive disorder.
Biogen to acquire Alcyone Therapeutics, enhancing CNS drug delivery tech with ThecaFlex DRx™ for SPINRAZA and future pipeline therapies.
Intellia finishes global Phase 3 HAELO trial enrollment for lonvo-z to treat hereditary angioedema, with topline data expected in early 2026.
Novo Nordisk’s REACH study shows Ozempic cut risk of heart attack, stroke, and related events by up to 25% vs. dulaglutide in Medicare patients.
Greenwich LifeSciences expands Phase III FLAMINGO-01 breast cancer trial to Ireland, partnering with Dr. Janice Walshe to advance GLSI-100 immunotherapy.
Grace Therapeutics strengthens IP estate with U.S. patent for GTx-104’s IV dosing regimen, extending protection to 2043 alongside FDA Orphan Drug exclusivity.
Vertex Pharmaceuticals announces reimbursement agreement with Italy’s AIFA, expanding access to CASGEVY® for eligible beta thalassemia and sickle cell disease.
Immix Biopharma surpasses 50% enrollment in NEXICART-2 trial of CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis, with data presented at ASCO 2025.
Quantum BioPharma gains Health Canada approval for Qlarity, supporting energy, endurance, and cognitive health, expanding presence with U.S. brand unbuzzd™.
ARS Pharma secures PMDA approval in Japan for neffy® nasal spray to treat anaphylaxis, expanding global access following U.S. and European launches.
Regeneron will donate up to 500 doses of its Ebola therapy Inmazeb® to the WHO, ensuring free access for low-income nations supporting outbreak response.
Syndax’s revumenib is now a Category 2A recommendation in NCCN AML guidelines for relapsed NPM1-mutated patients, with FDA priority review decision expected by Oct 2025.
Alvotech and Fuji Pharma receive Japan approvals for three biosimilars: denosumab, golimumab , and aflibercept, expanding their partnership portfolio.
Avalo Therapeutics appoints Kevin R. Lind to its Board, strengthening leadership as AVTX-009 Phase 2 trial for hidradenitis suppurativa progresses.
Actuate Therapeutics submits updated elraglusib data to FDA for upcoming FDA and EMA talks on pancreatic cancer therapy progress.
Lexicon sends extra Zynquista® data to FDA to support benefit-risk profile for type 1 diabetes; FDA feedback expected later this year
Plus Therapeutics gets $1.9M advance from CPRIT to support CNS cancer trials and diagnostic development.
Oryzon sponsors first study on Phelan-McDermid syndrome to assess its impact and guide development of new therapies.
Roche’s phase III evERA trial shows giredestrant plus everolimus significantly improves PFS in ER+ HER2- breast cancer, with positive safety profile and OS trend.
AstraZeneca and Amgen’s Tezspire receives CHMP recommendation for EU approval in chronic rhinosinusitis with nasal polyps, based on phase III WAYPOINT trial.
Alvotech and Advanz Pharma announce CHMP’s positive opinion for Gobivaz®, a Simponi® biosimilar, covering multiple inflammatory diseases across the EU and EEA.
AstraZeneca’s Koselugo receives CHMP backing for EU approval to treat adult NF1 patients with symptomatic, inoperable plexiform neurofibromas.
Alvotech announces CHMP positive opinion for AVT03, its proposed biosimilar to Prolia® and Xgeva®, with commercialization by STADA and Dr. Reddy’s in Europe.
Fortrea expands its Board with veteran William Sharbaugh, bringing 30+ years of pharma and CRO expertise to strengthen governance and drive growth.
Abselion expands its Amperia™ platform with the new Protein G Total Antibody Quantification Kit, enabling rapid, user-friendly, and accurate measurement across diverse antibody formats.
BPGbio strengthens leadership by bringing back NAi platform co-inventor Slava Akmaev as COO and Chief AI Officer to advance AI-driven drug discovery.
Biotech leader NeuraClick names industry veteran Daniel M. Bradbury to guide strategic and metabolic programs for its neurotherapeutics pipeline.
Amneal secures FDA approval for generic 0.01% bimatoprost ophthalmic solution, offering more accessible glaucoma and ocular hypertension treatment options
Vor Bio appoints Navid Z. Khan, Ph.D., as Chief Medical Affairs Officer to lead medical strategy and support autoimmune disease treatment programs.
Trethera secures $1.8M NIH funding to advance TRE-515 preclinical studies for Crohn’s disease, supporting development of a first-in-class oral therapy.
Sanofi commits $625M more to Sanofi Ventures to boost investments in biotech and digital health, accelerating next-gen therapies and innovation.
Biogen shares FDA feedback on high-dose nusinersen for SMA; clinical data intact, resubmission planned to advance global regulatory approvals.
Vertex teams up with Jayson Tatum to spotlight JOURNAVX, the first new non-opioid pain medicine class in 20+ years, approved by FDA in 2025.
Seres gets FDA feedback to finalize SER-155 Phase 2 for bloodstream infection prevention, while extending its cash runway into mid-2026.
Veru gains FDA clarity for enobosarm in obesity: approved endpoint is incremental weight loss with GLP-1 RAs, preserving muscle and driving fat reduction.
Allergan Aesthetics expands SKINVIVE® to 57 global markets in 2025, highlighting hydration, radiance, and natural skin quality.
Bristol Myers Squibb’s Phase 3 trial of iberdomide with daratumumab and dexamethasone shows significant MRD results in relapsed or refractory multiple myeloma.
Hanson Wade’s Genome Editing Therapeutics Summit 2025, Sept 30–Oct 1 in Boston, gathers 100+ experts to explore breakthroughs, clinical advances, and regulatory strategies in gene-editing therapies.