Explore the complete list of our presses below (Page 16 of 27):
Amneal receives FDA tentative approval for its first MDI inhaler, the generic version of QVAR, expanding its portfolio into complex respiratory therapies.
RemeGen’s Phase 3 gMG trial shows telitacicept sustained 48-week efficacy and favorable safety, with high MG-ADL and QMG improvement rates across patients.
FDA grants Priority Review to BioMarin’s PALYNZIQ sBLA to include adolescents aged 12–17 with PKU; EU submission to follow based on PEGASUS Phase 3 data.
AbbVie’s Phase 3 trials show RINVOQ (upadacitinib) met key endpoints in adults and adolescents with non-segmental vitiligo, with no new safety concerns.
Skillup To Scaleup opens a new academy in Ahmedabad to train 10 million pharma professionals by 2030.
Medicus partners with the Gorlin Syndrome Alliance to expand FDA compassionate access to SKINJECT™, its investigational microneedle therapy for BCC.
Novartis’ ianalumab met key endpoints in Phase III trials for Sjögren’s disease, showing sustained ESSDAI improvements and favorable safety versus placebo.
Elixir Software’s CEO Dr. Paul Faulder reveals how iTraX unifies pharma R&D teams, streamlines workflows, and accelerates discovery.
Akari Therapeutics appoints Dr. Sara Hurvitz to its new Scientific Advisory Board, strengthening its next-generation oncology ADC pipeline.
Alethio Therapeutics debuts with new leadership to develop two targeted ADC medicines for myeloproliferative neoplasms, chronic blood cancers.
Ritedose wins FDA approval to make Generic Tobramycin Inhalation Solution, becoming the U.S. leader with the largest nebulized drug portfolio.
Cartesian Therapeutics appoints Carsten Brunn, Ph.D., as Chairman, succeeding Carrie S. Cox, to strengthen leadership and advance cell therapy programs.
Arcutis launches FDA-approved ZORYVE® (roflumilast) cream 0.05% for children aged 2–5 with mild to moderate atopic dermatitis in the U.S.
Clearmind Medicine completes first cohort in its FDA-approved Phase I/IIa trial of CMND-100, a psychedelic-derived therapy for Alcohol Use Disorder.
Gefurulimab achieved statistically significant improvements in MG-ADL and QMG scores in the Phase III PREVAIL trial for AChR antibody-positive generalized MG.
Kiora joins Global Genes’ RARE-X Vision Consortium to accelerate research and improve clinical trial design for patients with rare ocular disorders.
Neuronetics signs a three-year exclusive deal with Elite DNA Behavioral Health to supply TMS devices and expand patient-support services across Florida.
Celularity forms a strategic partnership with DefEYE, securing exclusive rights and manufacturing roles for ophthalmic biologics following a $12M investment.
Foghorn Therapeutics reports progress in its ARID1B, CBP, and EP300 degrader programs, targeting key cancer mutations, moving toward proof of concept by 2026.
Lonza to acquire Redberry and its Red One™ platform, expanding rapid sterility and bioburden testing capabilities for pharma QC.
Kyowa Kirin International appoints Julie Dehaene-Puype as President for the International Region, succeeding Jeremy Morgan, supporting the company’s growth.
Oryzon Genomics enrolls first patient in RESTORE, a Phase Ib trial of iadademstat in sickle cell disease, evaluating safety, tolerability, and HbF induction.
Roche’s Phase III ALLEGORY study shows Gazyva achieved significant improvements in systemic lupus erythematosus, meeting all endpoints.
FDA issues a Complete Response Letter for Alvotech’s AVT05, a Simponi biosimilar; company lowers 2025 revenue and EBITDA guidance amid facility updates.
Merck Foundation launches $22M initiative to expand access to high-quality, equitable cardiac care across U.S. communities.
Benitec Biopharma appoints Dr. Sharon Mates to its Board, strengthening leadership as it advances its gene therapy programs.
Benitec’s BB-301 shows 100% response in OPMD trial, earning FDA Fast Track for its gene therapy targeting dysphagia.
Takeda’s QDENGA shows sustained 7-year protection and strong safety in Phase 3 dengue trial, supporting global immunization efforts.
Achieve Life Sciences reports final ORCA-OL trial results and FDA safety update, advancing cytisinicline toward approval for smoking cessation.
Abivax reports positive Phase 3 PRO results for obefazimod, showing quality-of-life benefits in ulcerative colitis patients.
Kailera Therapeutics adds industry veteran Frank K. Clyburn, Jr. to its Board of Directors, strengthening leadership as it advances its obesity treatment portfolio.
Life Biosciences appoints David Guyer, M.D., to its Board, enhancing leadership in cellular rejuvenation and age-related disease research.
Vor Bio names Dr. Jeremy Sokolove as Chief Medical Officer to lead clinical development and advance therapies for autoimmune diseases.
Rein Therapeutics gains FDA clearance to resume its Phase 2 RENEW trial of LTI-03 for idiopathic pulmonary fibrosis, advancing its fibrosis therapy program.
Ardena names Dipesh Patel as Chief Quality Officer and Peter Rose as Chief Information Officer, reinforcing its focus on quality and digital integration.
Sandoz to acquire JEB SAS from Evotec SE, gaining biosimilar manufacturing tech and advancing its USD 300B market strategy.
Ratio Therapeutics names Dr. Marcel Reichen as Chief Strategy Officer to enhance radiopharmaceutical innovation and strategic growth.
ARS Pharma launches “Get neffy on Us” to offer free virtual visits and $0 co-pay access for its needle-free allergy treatment, neffy.
Phathom begins a Phase 2 study of VOQUEZNA for treating eosinophilic esophagitis, aiming to expand GI treatment options.
Praxis secures FDA alignment on relutrigine study for SCN2A and SCN8A epilepsies, paving the way for a potential NDA in early 2026.
Prelude collaborates with Incyte on JAK2 program, advances KAT6A degrader, and pauses SMARCA2 projects to extend cash runway into 2027.
Valneva’s VLA1601 Zika vaccine shows strong immune response and safety in Phase 1, outperforming first-generation candidate.
Merck ends its co-development deal with Falk, gaining full global rights to MK-8690 and recording a $150 million R&D charge.
Merck receives $700 million from Blackstone to fund Phase 3 trials of sacituzumab tirumotecan targeting TROP2 across multiple cancers.
Tonix partners with MGH for a Phase 2 trial of TNX-1500 to prevent kidney transplant rejection with fewer immunosuppressive side effects.
Prelude partners with Incyte for its selective JAK2V617F inhibitor program targeting myeloproliferative neoplasms with potential for disease modification.
Novo Nordisk’s STEP UP trial reveals Wegovy® helps patients achieve obesity and heart health goals, cutting risks beyond weight reduction.
Rhythm Pharmaceuticals secures public coverage for IMCIVREE across major Canadian provinces, improving access for Bardet-Biedl syndrome patients with obesity.
Design Therapeutics progresses GeneTAC® candidates DM1, FA, and FECD, with clinical milestones set for 2026 and a new board addition strengthening leadership
Marker Therapeutics appoints biotech leader Kathryn Penkus Corzo to its Board, reinforcing its mission to advance MAR-T cell therapies for cancer.
Charles River Laboratories’ strategic review leads to focused growth investments, divestitures, $295M in savings, and a new $1B stock repurchase program.
Jaya Biosciences secures a U.S. patent for methods to treat neurological diseases, including Alzheimer’s, strengthening its global gene therapy IP portfolio.
Clearmind files a new patent in South Korea for MEAI, a non-hallucinogenic compound for depression, strengthening its global neuroplastogen IP portfolio.
Jupiter Neurosciences receives FDA clearance to start a Phase 2a trial of JOTROL™ for Parkinson’s disease, marking a key milestone in its clinical development.
Normunity begins Phase 1 trial of NRM-823, a novel T cell engager targeting tumor-specific antigens in solid tumors, marking its move to a clinical-stage company.
Turn Therapeutics names Andrew Scott as VP of Corporate Communications to lead investor relations, capital markets, and growth strategy initiatives
Averoa gains UK MHRA approval for XOANACYL, a dual-action oral therapy for CKD complications.
Astria Therapeutics’ navenibart delivers robust HAE attack prevention and favorable safety in ALPHA-STAR trial, with all patients joining the long-term study.
ORIC Pharmaceuticals reports in Cancer Research that enozertinib, a selective EGFR exon 20 inhibitor, achieves complete systemic and brain responses in NSCLC.
Cue Biopharma partners ImmunoScape to develop a Seed-and-Boost in vivo T cell therapy for solid tumors, combining Immuno-STAT and proprietary TCR platforms.
Alvotech and Advanz Pharma gain UK MHRA approval for Gobivaz®, a biosimilar of Simponi® (golimumab), for treating multiple immune-mediated diseases.
Novo Nordisk’s CagriSema shows major blood pressure and inflammation reduction in obesity trial, suggesting added heart health benefits beyond weight loss.
Coherus Oncology names Arvind Sood Chief Strategy & Corporate Affairs Officer to drive partnerships and strengthen its oncology growth strategy.
Nasus Pharma receives Health Canada approval to begin a Phase 2 trial of NS002, its intranasal epinephrine powder for treating anaphylaxis and severe allergies.
Novo Nordisk reaches agreement with the U.S. Administration to cut prices and expand access to Wegovy® and Ozempic® under Medicare and Medicaid from 2026.
RenovoRx appoints UCLA pancreatic cancer expert Dr. Timothy Donahue to its Scientific Advisory Board to advance targeted therapies for hard-to-treat cancers.
Merck’s Phase 3 CORALreef HeFH trial shows enlicitide, an oral PCSK9 inhibitor, cut LDL-C by 59% at 24 weeks with strong one-year durability safety.
Baxdrostat met its Phase III endpoints, reducing 24-hour systolic BP by 14 mmHg in resistant hypertension and achieving strong efficacy and safety results.
Roche’s BTK inhibitor fenebrutinib met primary endpoints in RMS and PPMS Phase III trials, showing potent efficacy and consistent safety across both studies.
Vaxxas adds Brent MacGregor to its Board as it advances HD-MAP, a needle-free vaccine patch, toward commercialization and global vaccine accessibility.
Acumen Pharmaceuticals appoints biotech veteran George Golumbeski as Chairman to guide Alzheimer’s drug development and drive strategic growth.
Celldex names industry veteran Teri Lawver as SVP and CCO, succeeding Richard Wright, to lead commercialization and drive growth in immunology and inflammation.
HOPE Therapeutics introduces the one-day Ampa ONE-D TMS protocol in Florida, offering rapid, effective treatment for patients with resistant depression.
BioCardia and Henry Ford Health enroll first patient in Phase 3 CardiAMP HF II trial evaluating autologous cell therapy for ischemic heart failure.
Propanc Biopharma raises up to $100M from Hexstone Capital to accelerate proenzyme cancer therapy development and expand its digital asset portfolio.
Novartis inaugurates a 10,000-sq-ft RLT facility in Carlsbad, boosting U.S. cancer care capacity under its $23B investment plan to expand innovation.
AnaptysBio’s rosnilimab was safe but failed to meet efficacy goals in a Phase 2 ulcerative colitis trial, leading to its discontinuation and $10M of savings.
Transition Bio and Voyager Therapeutics form a partnership to develop TDP-43–targeting small molecules for ALS and FTD, with potential deal value up to $500M.
Reviva earns EU patent for brilaroxazine in pulmonary fibrosis, adding to U.S., China, and Japan, drug shows strong efficacy in CNS and inflammatory disorders.
MB-105 CAR-T receives FDA RMAT designation, accelerating development for relapsed or refractory CD5-positive T-cell lymphoma.
Ariceum starts Phase 1/2 trial of 225Ac-SSO110 for ES-SCLC and Merkel Cell Carcinoma, targeting aggressive neuroendocrine tumors.
Quoin Pharmaceuticals reaches 4% and 5% rapamycin concentrations in its topical and patch systems, advancing rare disease therapies.
BPGbio names John Dvor EVP to drive corporate growth, partnerships, and AI-driven biotech innovation.
Svan Analytical to showcase smart compliance, aseptic and analytical solutions at CPHI PMEC India 2025, Hall 15, Stall D32.
Novartis’ new antimalarial GanLum achieves 97.4% cure in Phase III study, offering first major malaria treatment breakthrough in 25 years.
Neuronetics’ NeuroStar TMS gains TRICARE coverage for adolescents aged 15+, expanding access to safe, effective depression therapy across 23 U.S. states.
Apellis reports five-year GALE study data showing SYFOVRE delayed lesion growth by ~1.5 years in geographic atrophy from AMD, confirming long-term efficacy.
Thermo Fisher’s EXENT System earns FDA 510(k) clearance, bringing automated, high-sensitivity testing to improve diagnosis of multiple myeloma.
Sarah Cannon Research Institute and Bristol Myers Squibb expand collaboration to speed oncology research and bring clinical trials closer to patients in U.S.
Cortland Biomedical implements key leadership changes to enhance operations, strengthen strategy, and support continued global business expansion.
LB Pharmaceuticals appoints Kaya Pai Panandiker as Chief Commercial Officer to lead commercial strategy, growth, and advance its neuropsychiatric pipeline.
BetaGlue Therapeutics gains MHRA approval to begin a clinical trial of YntraDose™ for unresectable locally advanced pancreatic cancer, advancing oncology innovation.
Velocity Clinical Research names Drew Reina as CRO to strengthen strategic partnerships, drive growth, and enhance collaboration with Sponsors and CROs.
Moleculin teams up with UNC-Chapel Hill for grant-funded research evaluating Annamycin as a potential new treatment for pancreatic cancer.
Immix Biopharma appoints Michael Grabow as CCO to lead the global launch of NXC-201, a potential first therapy for relapsed/refractory AL amyloidosis.
Longeveron secures a U.S. patent for using its stem cell therapy to treat aging-related frailty linked to inflammaging, extending protection through 2038.
FDA accepts Outlook Therapeutics’ resubmitted BLA for LYTENAVA™, setting a PDUFA date of December 31, 2025, advancing the wet AMD ophthalmic therapy.
Salarius and Decoy finalize their merger, forming Decoy Therapeutics to advance IMP3ACT-engineered peptide-conjugate antivirals and oncology candidates.
Legend Biotech launches a state-of-the-art 31,000-sq-ft R&D center in Philadelphia, strengthening its U.S. cell therapy footprint.
Amneal wins FDA approval for the first generic iohexol injection, expanding access to a key contrast agent used across imaging procedures starting in early2026
Eisai and Biogen secure MHRA approval for LEQEMBI’s once-every-four-weeks maintenance dosing, a long-term treatment option for early Alzheimer’s disease.
ORIC reports new Phase 1b data shows ORIC-944 plus AR inhibitors is well tolerated in heavily pretreated metastatic castration-resistant prostate cancer patients.
Medicus secures UK regulatory and ethical approvals to expand its Phase 2 trial of Doxorubicin Microneedle Array for non-invasive treatment of BCC
Bry-Air unveils the P80x dehumidifier with MOF rotor tech, delivering higher performance and major energy savings for pharma environments.
Biogen acquires Alcyone Therapeutics, adding ThecaFlex DRx™ to its CNS portfolio to improve intrathecal delivery and support future SPINRAZA use.
COSCIENS Biopharma appoints Peter Puccetti as Interim CEO after Anna Biehn’s exit, guiding cost reduction, operational focus, and strategic realignment.
Silo Pharma teams with Allucent to support FDA IND filing for SPC-15, an intranasal therapy targeting PTSD, with Phase 1 trials planned for 2026
Onco360 selected as pharmacy partner for Komzifti™, providing adult AML patients with NPM1 mutation access and support for this targeted therapy.
Dewpoint Therapeutics’ DPTX3186 receives FDA Fast Track for gastric cancer, aiming to speed development of this first-in-class condensate modulator therapy.
Apollomics expands its board with Dr. Ya-Chi (Claudia) Huang, strengthening audit and corporate governance committees.
Clearmind seeks Israeli patent for MEAI-PEA therapy, offering depression relief without hallucinogenic effects.
Johnson & Johnson will acquire Halda Therapeutics, advancing HLD-0915 for advanced prostate cancer, backed by promising Phase 1/2 data.
Akari Therapeutics names finance expert Kameel D. Farag as Interim CFO to support growth and advance its next-generation ADC development strategy.
Neurona Therapeutics appoints Dr. Eduardo Dunayevich as CMO to guide clinical strategy ahead of the pivotal Phase 3 EPIC study of NRTX-1001 for focal epilepsy.
Zymeworks appoints Scott Platshon as Acting CIO to oversee future cash flows from Ziihera and other licensed assets, strengthening its long-term growth strategy.
MediciNova names Dr. Christopher Breder as Clinical and Regulatory Advisor to strengthen its drug development strategy and advance neuroscience programs
Annovis schedules an FDA meeting for its PDD program and reconfirms FDA support for its Phase 3 Alzheimer’s trial, advancing buntanetap development.
FDA approves Genmab’s EPKINLY + R2 for relapsed or refractory follicular lymphoma, offering stronger responses and improved progression-free survival.
HCW Biologics doses the first patient in its Phase 1 trial of HCW9302, a Treg-activating IL-2 fusion therapy developed to treat alopecia areata.
Merck’s Phase 2 CADENCE trial shows WINREVAIR significantly reduces pulmonary vascular resistance in CpcPH due to HFpEF, with safety consistent with prior data.
Roche’s Positive lidERA Phase III Data Support Giredestrant as a Promising New Adjuvant Therapy for ER-Positive Breast Cancer
Thermo Fisher launches its Philadelphia ATxCC, expanding U.S. support for cell and gene therapy innovation with advanced labs and collaborative space.
AbbVie’s EPKINLY + R2 secures full FDA approval for R/Rfollicular lymphoma after strong Phase 3 results showing major gains in response and survival.
Tempest acquires dual-target CAR-T programs from Factor Bioscience expanding its oncology pipeline and extending its cash runway through mid-2027.
Novartis will build a flagship manufacturing hub in North Carolina, expanding biologics, sterile, and oral dosage production while creating thousands of jobs.
Regeneron’s EYLEA HD secures FDA approval for RVO, offering extended dosing options supported by QUASAR trial and ongoing updates to PFS manufacturing plans.
The EU approves Libtayo for high-risk CSCC, backed by Phase 3 data showing a 68% reduction in recurrence or death.
Elicio Therapeutics names Marc Wolfgang as CTO to strengthen CMC, manufacturing, and development ahead of key late-stage milestones.
EU approves subcutaneous Lunsumio for relapsed follicular lymphoma, offering faster one-minute dosing with strong efficacy and flexible treatment options.
Mesoblast and NIH BMT CTN begin a pivotal Phase 3 trial evaluating Ryoncil for adults with severe steroid-refractory aGvHD to improve survival outcomes.
Crinetics begins Phase 3 CAREFNDR trial evaluating once-daily paltusotine for carcinoid syndrome to improve symptom control and long-term outcomes.
Inhibikase Therapeutics advances IKT-001 into a global adaptive Phase 3 IMPROVE-PAH study to improve pulmonary vascular resistance and exercise capacity.
Nasus Pharma appoints Eyal Rubin as Executive Vice President and CFO to lead financial strategy and support clinical and commercial growth.
Evaxion reports new data showing protective effects of novel AI-discovered antigens in its multi-component CMV vaccine EVX-V1.
JetSpray to unveil advanced CIP systems at CPHI & PMEC India 2025, highlighting precision, audit-ready hygiene, and high-efficiency cleaning solutions for pharma.
CNSide Diagnostics signs national deal with Humana, expanding coverage of CNSide® CSF Tumor Cell Enumeration test to 67M people for leptomeningeal metastases care.
Novartis’ Itvisma becomes the first gene replacement therapy approved for SMA patients aged two to adulthood, offering sustained motor function improvement.
The European Commission approves Breyanzi for R/R mantle cell lymphoma, offering high response rates and durable benefit after BTK inhibitor therapy.
Plus Therapeutics progresses its REYOBIQ radiotherapy program after an FDA Type B meeting, addressing need for treatments for leptomeningeal metastases.
Biogen and Dayra Therapeutics team up to develop oral macrocyclic peptides to deliver biologic-like efficacy in immunology, backed by a $50M upfront payment.
Tonix secures FDA IND clearance to advance TNX-102 SL into a pivotal Phase 2 study for major depressive disorder, addressing need for better treatment options.
Novo Nordisk reports oral semaglutide failed to slow Alzheimer’s progression in phase 3 trials, despite biomarker improvements & consistent safety profile.
Tiziana Life Sciences’ Phase 2 nasal foralumab trial for ALS accepted into Healey ALS MyMatch Program, supported by ALS Association and NEALS Consortium.
Teva secures EU approval for PONLIMSI and DEGEVMA, its denosumab biosimilars to Prolia and Xgeva, expanding access to high-quality biologic therapies in Europe.
Clearmind Medicine begins enrolling patients at Tel Aviv Sourasky Medical Center in its Phase I/IIa CMND-100 trial for Alcohol Use Disorder.
Valneva’s VLA15 Lyme vaccine shows strong immune response and favorable safety six months after third booster, supporting annual vaccination potential.
FDA extends review of Ascendis’ TransCon CNP (navepegritide) for children with achondroplasia to Feb 28, 2026 after major NDA amendment.
LIXTE acquires Liora Technologies, adding the advanced LiGHT proton therapy system while progressing LB-100 clinical trials in a new cancer treatment paradigm.
Imfinzi plus FLOT chemotherapy wins US approval for resectable gastric and GEJ cancers after Phase III data show major gains in event-free and overall survival.
Eisai submits sBLA for LEQEMBI’s weekly subcutaneous autoinjector, aiming to offer Alzheimer’s patients an at-home alternative to IV dosing.
Novo Nordisk’s amycretin delivers strong HbA1c reductions and weight loss in phase 2 trials, supporting its move into phase 3 development for type 2 diabetes.
The EU has approved Dupixent for moderate-to-severe CSU in patients 12+, offering a new first-line targeted option for those unresponsive to antihistamines.
GENFIT appoints Dr. Pejvack Motlagh as Chief Medical Officer to lead clinical strategy and advance therapies for rare, life-threatening liver diseases.
Freya Pharma becomes Arletta Pharma, marking a major step toward innovative treatments for FSIAD and advancing women’s sexual health.
Dupixent secures EU approval as the first targeted therapy in 10 years for chronic spontaneous urticaria, offering improved relief for uncontrolled symptoms
Kiora Pharmaceuticals receives a new U.S. patent for novel KIO-104 formulations, expanding delivery options for KIO-104’s retinal inflammation therapy.
Regeneron and Tessera form a global partnership to develop TSRA-196, a gene-writing therapy targeting the genetic cause of alpha-1 antitrypsin deficiency.
Medicus Pharma names President Carolyn Bonner as its new CFO, adding financial leadership to her strategic role as the company advances clinical development.
Decoy Therapeutics and Texas Biomed join forces to test peptide fusion inhibitors against various influenza strains, developing of broad-spectrum antivirals.
The FDA approves Amneal’s generic version of RESTASIS®, a preservative-free cyclosporine 0.05% eye drop for dry eye patients, entering a $2B U.S. market.
COSCIENS signs a 10-year exclusive deal with Wuzhou for Macrilen distribution across Hong Kong, Macao, Singapore, Guangdong, and Hainan.
Mapi Pharma to present partnering opportunities and long-acting depot innovations at the 8th Evercore Healthcare Conference in Miami.
CLN-049 receives FDA Fast Track for relapsed/refractory AML; Phase 1 data to be presented at ASH Annual Meeting.
University of Bonn enrolls first patients in Biodexa’s Phase 3 Serenta trial evaluating eRapa for familial adenomatous polyposis.
Tinlarebant shows positive Phase 3 results in Stargardt disease, reducing retinal lesion growth and marking a historic treatment milestone.
Greg Di Russo joins Kriya Therapeutics as CMO to lead clinical strategy, medical affairs, and drug safety across its expanding gene therapy pipeline.
Propanc requests Spain foreign filing license for two patents on resistant cancer and fibrosis treatments via its Australian subsidiary.
Dogwood Therapeutics files new IP for synthetic Halneuron®, potentially extending exclusivity to 2045 as its Fast Track non-opioid pain therapy progresses.
Thermo Fisher boosts its Asian bioprocessing network with a new Hyderabad center and expanded hubs in Korea and Singapore, enhancing biologics innovation.
Amneal secures FDA approval for its generic albuterol inhalation aerosol, strengthening its growing respiratory portfolio following QVAR® generic approval.
DiagnoSearch Life Sciences marks 30 years of scientific innovation, global clinical research excellence, and commitment to quality and regulatory integrity.
Roche’s new point-of-care PCR test for pertussis gains FDA clearance, CLIA waiver, and CE IVDR certification, improving rapid diagnosis and early treatment.
AstraZeneca’s baxdrostat receives FDA Priority Review for hard-to-control hypertension, backed by Phase 2 results showing significant blood-pressure reductions.
Drs. Richard Colvin and John McHutchison join Comanche Biopharma to advance CBP-4888 for sFlt1-mediated preterm preeclampsia globally.
Dr. Carlos Quezada-Ruiz joins Alkeus Pharmaceuticals to lead Phase 3 development of gildeuretinol for Stargardt disease, advancing vision-preserving therapies
FDA grants Fast Track to Sangamo’s ST-503, an epigenetic regulator for intractable small fiber neuropathy pain, supporting accelerated development.
Dr. Mary Tagliaferri joins ADARx Pharmaceuticals’ board to support growth and advancement of its RNA therapeutics pipeline.
LOMECEL-B gains Canadian patent protection until 2037 for treating aging frailty and non-ischemic dilated cardiomyopathy.
Dr. James Izanec joins Palisade Bio to lead clinical development of PDE4 programs for inflammatory and fibrotic diseases.
Dr. Petra Kaufmann joins Ovid Therapeutics as CMO to lead clinical and regulatory strategy for CNS therapies, including OV329 and KCC2 activators.
Bristol Myers Squibb will enrol more ADEPT-2 patients after identifying site irregularities, advancing Cobenfy’s development for Alzheimer’s psychosis.
New research shows Artelo’s SBFI103 eases anxiety and depression behaviours, boosts endocannabinoid signalling, and preserves neurogenesis in stress models.
Sapu003’s IV formulation reduces everolimus GI exposure by up to 67-fold, improving tolerability while enhancing systemic delivery and antitumor potential.
NEJM publishes strong Phase 3 results for EMPAVELI, showing major improvements in proteinuria, kidney function, and C3 clearance in C3G and IC-MPGN patients.
Marvin Slosman joins BioCardia’s Board as Dr. Richard Krasno steps down after nine years, strengthening leadership for cardiovascular and pulmonary therapies.
Dr. Darshan Dalal joins Actithera as CMO to lead clinical strategy and advance FAP-targeting radioligand therapy into clinical trials.
Former FDA division director Dr. Lee S. Simon joins DIMERx to guide clinical development and regulatory strategy for DMX-101, a non-addictive analgesic candidate.
Breyanzi wins FDA approval for adults with relapsed or refractory MZL after two prior treatments, supported by strong TRANSCEND FL response and durability data.
Takeda closes its collaboration with Innovent, securing global rights to oncology assets IBI363 and IBI343 and investing US$1.2B to expand cancer portfolio.
Praxis announces early-stop EMBOLD success for relutrigine in SCN2A/SCN8A DEEs. FDA to review data soon, with NDA timing to be decided after the meeting.
Merck’s EXZOLT CATTLE-CA1 earns FDA conditional approval for treating New World screwworm and fever ticks, with U.S. availability expected in early 2026.
Praxis gains FDA alignment after a successful pre-NDA meeting; plans to submit its essential tremor therapy NDA in early 2026, addressing unmet medical need.
Sandoz completes the acquisition of JEB SAS, gaining the Toulouse site and continuous manufacturing tech to strengthen its global biosimilars strategy.
Regeneron reports strong Phase 1/2 results for Lynozyfic in newly diagnosed multiple myeloma, with rapid deep responses and manageable safety.
Pfizer’s Phase 3 BASIS study shows HYMPAVZI delivers a 93% reduction in bleeding and improves quality of life for hemophilia A and B patients with inhibitors.
Amit Munshi joins Arcutis Board as founder Bhaskar Chaudhuri retires after nine years, continuing as consultant to support company growth and strategy.
LEQEMBI® (lecanemab) now on China’s Commercial Insurance Innovative Drug List, expanding access for early Alzheimer’s patients starting Jan 2026.
Immutep licenses Efti to Dr. Reddy’s for development and sales outside North America, Europe, Japan, and Greater China, unlocking global cancer therapy access.
Abeona administers FDA-approved ZEVASKYN for RDEB at Stanford, marking the first commercial treatment for this rare and serious genetic skin disorder
Moleculin Biotech teams with Spain’s CIC biomaGUNE to launch preclinical studies of Annamycin for aggressive glioblastoma treatment.