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Clearmind’s Phase I/IIa CMND-100 trial in alcohol use disorder continues after DSMB safety review confirms favorable tolerability in the second cohort.
Genvor enters the health and wellness sector using its AI-driven BioCypher platform to develop peptide-based consumer products for recovery, immunity and wellness
HUTCHMED doses first patient in Phase I/IIa trial of HMPL-A580, an EGFR-targeted ATTC with PI3K/PIKK inhibitor payload for advanced solid tumors.
NervGen Pharma appoints Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as SVP as NVG-291 spinal cord injury program advances.
Lifecore Biomedical to produce engineering and clinical batches of DT-001 for Indomo as the acne therapy advances toward Phase 2 trials with the ClearPen device.
Allergan Aesthetics reports GLP-1 weight-loss patients increasingly seek hyaluronic acid fillers to address facial volume loss after rapid weight reduction.
Thermo Fisher Scientific launches an $18M immunodiagnostics distribution centre in Uppsala to boost global supply of allergy and autoimmune IVD tests.
Glenmark Pharmaceuticals receives U.S. Food and Drug Administration approval for generic Fluticasone Propionate inhaler with 180-day CGT exclusivity in the U.S.
Achieve Life Sciences reports Phase 3 data showing Cytisinicline helps smokers quit regardless of prior cessation therapy or quit attempts.
Entera Bio submits Phase 3 protocol amendment to FDA for oral teriparatide candidate EB613 to treat osteoporosis.
Nxera Pharma seeks South Korea approval for insomnia drug Daridorexant following successful Phase III trial results.
Keros Therapeutics appoints Charles Newton to its board as rinvatercept (KER-065) advances, reinforcing finance and capital markets oversight.
Zealand Pharma reports Phase 2 results showing up to 10.7% weight loss with Petrelintide in adults with obesity.
Tevogen Bio Holdings Inc. signs LoI to explore acquiring Apozeal Pharmaceutical Inc. to strengthen U.S. generics manufacturing and drug supply.
Tenaya Therapeutics and Alnylam Pharmaceuticals collaborate to identify genetic targets and develop RNAi-based treatments for cardiovascular disease.
Roche Holding AG reports strong Phase II results for petrelintide, showing significant weight loss and favorable safety in obesity patients.
Pacific Biosciences of California Inc. appoints Recursion co-founder Christopher Gibson to its board, boosting AI and data science expertise.
Kestrel Therapeutics Inc. gets FDA clearance for KST-6051, advancing a Phase 1 trial in KRAS-mutant cancers.
Invivyd Inc. appoints Dr. Michael Mina as CMO to advance monoclonal antibody programs for viral prevention.
Galapagos NV appoints Tania Philipp as Chief Human Resources Officer to strengthen leadership and support its ongoing strategic transformation.
Avalyn Pharma names former Blueprint Medicines CEO Kate Haviland to its board as it advances inhaled antifibrotic therapies for pulmonary fibrosis.
Sangamo Therapeutics submits clinical and preclinical modules to the U.S. Food and Drug Administration for Fabry gene therapy ST-920 BLA review.
Mineralys Therapeutics wins U.S. Food and Drug Administration NDA acceptance for hypertension drug lorundrostat; PDUFA decision set for Dec 22, 2026.
LB Pharmaceuticals names neuroscience executive Robert Lenz to its board as it advances late-stage development of LB-102.
Cytek Biosciences celebrates one year of its Singapore hub, boosting APAC manufacturing, training, and cell analysis support.
Biofrontera Inc. reports positive Phase 2b results for Ameluz PDT, supporting further development for moderate to severe acne treatment.
AEON Biopharma names John Bencich CFO as it prepares regulatory progress for ABP-450, a biosimilar to BOTOX.
Actuate Therapeutics begins expanded research to test elraglusib with emerging RAS-targeted therapies, aiming to overcome resistance in RAS-driven cancers.
BSE-listed Anuh Pharma secures EDQM GMP approval for Tarapur facility after successful European audit, reinforcing global quality standards for API manufacturing.
Santhera Pharmaceuticals names Marc Clausse Chief Commercial Officer to expand global access to AGAMREE for Duchenne muscular dystrophy.
Propanc Biopharma teams with FyoniBio GmbH to develop an LC-MS PK assay supporting PRP therapy in a first-in-human cancer study.
Polyrizon Ltd. completes GMP clinical batch with Eurofins CDMO AmatsiAquitaine S.A.S, advancing its intranasal therapy toward a U.S. study.
Oragenics, Inc. receives HREC approval in Australia to start Phase IIa trial of ONP-002, an intranasal therapy for concussion.
Karen Basbaum joins MBX Biosciences as CBO to advance strategic growth and precision peptide therapies.
Celularity enters strategic partnership to monetize placental-derived biomaterials while focusing on longevity-focused cellular therapies.
Cassava Sciences becomes Filana Therapeutics to focus on filamin A-based treatments for CNS disorders, including TSC-related epilepsy.
Curanex adds two experts to its Scientific Advisory Board, bringing 75 years of experience to strengthen strategy and drug development.
Mainz Biomed appoints Robert Liscouski as Chairman and will rebrand as Quantum Cyber with new Nasdaq ticker QUCY launching March 12, 2026.
Quoin Pharmaceuticals earns FDA Fast Track Designation for QRX003 lotion, advancing treatment development for rare Netherton Syndrome.
Bavarian Nordic and Serum Institute sign a new manufacturing deal to scale production of the CHIKV VLP chikungunya vaccine.
Clearmind starts enrolling the third cohort in its FDA-approved Phase I/IIa trial of CMND-100, a non-hallucinogenic treatment for alcohol use disorder.
Commit Biologics names Thomas Andresen CEO as it advances toward clinical development following €21.5M in seed funding.
Telix resubmits its Pixclara NDA to the FDA with new data, aiming to improve glioma imaging and provide clearer diagnosis for adult and pediatric patients.
Firebrick Pharma Limited appoints Nilesh Wadhwa to lead global business development and licensing from April 2026.
Roche scales AI infrastructure with NVIDIA GPUs to speed drug discovery, genomics analysis, and digital diagnostics innovation.
Rhythm Pharmaceuticals, Inc. says Phase III EMANATE trial of Setmelanotide missed primary endpoints but showed benefit in genetic obesity subgroups.
Baxter CFO Joel Grade steps down; Anita Zielinski named interim CFO as the company begins search for a permanent successor.
Monte Rosa Therapeutics, Inc. partners with Johnson & Johnson to study MRT-2359 with ERLEADA in Phase II metastatic prostate cancer trial.
Greenwich LifeSciences, Inc. moves Phase III GLSI-100 trial forward as FDA approves commercial GP2 supply for breast cancer recurrence prevention.
European Commission clears AstraZeneca’s Imfinzi plus chemotherapy for Gastric Cancer based on strong Phase III survival data.
Amlogenyx Inc. says preclinical studies show AM805 gene therapy reduces brain amyloid in Alzheimer’s disease.
George Medicines signs licensing deal with Arrotex Pharmaceuticals to commercialize GMRx2 for Hypertension in ANZ.
HCW Biologics Inc. study finds HCW9206 enhances CAR‑T cell therapy potency and persistence in preclinical cancer and HIV models.
Recludix Pharma promotes Ajay Nirula to president and Catherine Bovenizer to CFO to advance innovation and growth.
Spyre Therapeutics completes RA enrollment in SKYWAY Phase 2 study of SPY072. Topline data expected in Q3 2026.
Cogent Biosciences NDA for bezuclastinib in non-advanced systemic mastocytosis accepted by U.S. Food and Drug Administration; decision due Dec 2026.
Allergan Aesthetics launches Skin Quality Index to standardise aesthetic terminology and enhance patient-provider communication in skin treatment planning.
Alamar Biosciences introduces NULISAseq Neuro 220 Panel for ultra-sensitive multiplex detection of neurological biomarkers in neurodegenerative disease studies.
Clearmind Medicine Inc. receives publication of six Hong Kong patents for PEA-based psychedelic formulations to expand its mental health drug pipeline.
Dyadic Applied BioSolutions partners with Integrated Biotherapeutics to distribute recombinant proteins worldwide under an OEM agreement.
NovaBridge Biosciences gains positive U.S. Food and Drug Administration feedback on accelerated approval strategy for givastomig in gastroesophageal cancer.
Transpire Bio names Ewan Livesey Head of Business Development to drive licensing and partnerships for its inhaled therapeutics pipeline.
Polyrizon signs a CRO pact to run GLP biocompatibility tests under ISO 10993, targeting first-in-human trials for its intranasal device platform.
PolyPid secures a $4.3M PDUFA fee waiver from FDA, clearing the path to file its NDA for D-PLEX100 to prevent surgical site infections.
Zydus and Lupin partner to co-market semaglutide injection in India under five brand names, targeting type 2 diabetes and obesity management.
Pfizer's Phase 2 FOURLIGHT-1 trial shows atirmociclib plus fulvestrant improves PFS in HR+/HER2- metastatic breast cancer post CDK4/6 therapy.
Ascendis Phase 2 New InsiGHTS trial shows once-weekly TransCon hGH matches daily somatropin growth rates in children with Turner syndrome.
HCW Biologics receives $7M upfront from Beijing Trimmune for HCW11-006 China license, with milestones, royalties, and reacquisition rights retained.
Neuronetics appoints Dan Reuvers as President and CEO from March 23, 2026, succeeding Keith Sullivan who retires after five years at the helm.
NCCN 2026 guidelines now include ANKTIVA plus BCG for BCG-unresponsive papillary-only NMIBC, expanding coverage beyond CIS bladder cancer patients.
Greenwich LifeSciences Phase III FLAMINGO-01 data shows GLSI-100 cuts breast cancer recurrence to 0.7% annually, an 83% drop vs historical control.
Clearmind Medicine advances CMND-100 Phase I/IIa trial third cohort for alcohol use disorder with no serious adverse events at Yale and Johns Hopkins.
Collegium Pharmaceutical acquires AZSTARYS from Corium for $650M, adding the first dual-release ADHD capsule to its portfolio alongside JORNAY PM.
Curia expands Glasgow sterile fill-finish facility by 2027 and upgrades its CHO-based cell line platform with 6x higher titers for biologics partners.
Kaida BioPharma appoints full executive team to advance KAD-101, a prolactin receptor antagonist, toward IND filing and first-in-human trials for recurrent ovarian cancer.
Remix Therapeutics gains FDA Fast Track for REM-422, a first-in-class MYB mRNA degrader in Phase 1/2 ARIA trial for recurrent or metastatic ACC.
Annovis Bio partners with NeuroRPM to use an FDA-cleared AI platform in its buntanetap Parkinson's trial, tracking tremor and bradykinesia as digital biomarkers.
BOOST Pharma appoints Elaine Jones, PhD, ex-Pfizer Ventures, as Board Chair to advance BT-101 cell therapy into Phase III trials for brittle bone disease.
Allergan Aesthetics launches AA Signature™ Skin360+ and global research at AMWC 2026, showing 62% of patients prefer structured combination aesthetic treatment plans.
Chugai submits Japan device application for ranibizumab Port Delivery System, backed by Phase III Archway and Pagoda trial data; drug filing targeted for 2026.
Greenwich LifeSciences expands FLAMINGO-01 Phase III trial with City of Hope sites, advancing GLSI-100 HER2-positive breast cancer vaccine with Dr. Hope Rugo as investigator.
CellCarta and Biofidelity sign exclusive multi-year deal for Aspyre® Lung in clinical trials, offering 4–5 day targeted genomic testing with 99% success rates for lung cancer studies.
Pfizer's TALAPRO-3 Phase III trial shows TALZENNA plus XTANDI significantly extends progression-free survival in HRR-mutated metastatic castration-sensitive prostate cancer.
FDA approves Novo Nordisk's Wegovy® HD semaglutide 7.2mg for chronic weight management with 20.7% weight loss in STEP UP trials; U.S. launch set for April 2026.
FDA approves Rhythm Pharmaceuticals' IMCIVREE® as first therapy for acquired hypothalamic obesity, with Phase III TRANSCEND data showing 18.4% placebo-adjusted BMI reduction.
FDA approves GSK's Lynavoy (linerixibat) as first U.S. therapy for cholestatic pruritus in PBC; Phase III GLISTEN trial shows rapid, sustained itch relief within two weeks.
Novartis acquires SNV4818, a mutant-selective PI3Kα inhibitor for HR+/HER2- breast cancer, from Synnovation in a deal worth up to $3B.
Macau approves ImmunityBio's ANKTIVA for bladder cancer, marking the therapy's first authorisation in Asia via reliance on US and EU reviews.
Opdivo wins new US and EU approvals for classical Hodgkin lymphoma, supported by strong survival and progression-free outcomes.
Glenmark launches affordable semaglutide GLIPIQ in India for Type 2 diabetes, offering vial and pen options with a patient support program.
Zydus launches semaglutide injection in India with reusable multi-dose pen, cutting diabetes and obesity treatment costs after patent expiry.
HUTCHMED starts Phase III trial of HMPL-760 plus R-GemOx in relapsed/refractory DLBCL in China; 240 patients planned for enrollment.
Roche halts emugrobart trials in SMA and FSHD due to limited efficacy, while the obesity program continues; no safety issues reported.
GSK's B7-H3 ADC Ris-Rez earns Japan orphan status for SCLC after promising early data, now holding six global regulatory designations including FDA Breakthrough Therapy.
Roche launches Building 92 in Basel for its IHB, combining organoids, organ-on-chip & AI to speed up drug discovery, backed by CHF 41B Swiss investment.
Pfizer and Valneva report Phase 3 results for PF-07307405 Lyme vaccine with ~74% efficacy and plan regulatory submissions.
Tarsus earns $15M after China approves TP-03 for Demodex blepharitis; Grand Pharma to commercialise across Greater China.
Oryzon gains US patent for iadademstat and venetoclax combo in AML, extending protection to 2039 and supporting ongoing clinical trials.
Theriva aligns with FDA on Phase 3 design for VCN-01 in metastatic pancreatic cancer with chemotherapy, supporting future biologics license plans.
Japan approves Chugai’s Lunsumio and Polivy combo for relapsed large B-cell lymphoma based on Phase 3 data showing improved response and PFS.
Adial Pharmaceuticals backs AD04 under U.S. bill for alcohol use disorder, expanding research access and supporting non-abstinence treatment for veterans.
AbbVie partners with MLB to expand cancer research funding via Striking Out Cancer, supporting nationwide awareness and treatment through per-strikeout donations.
Thermo Fisher acquires Clario to boost clinical trial data solutions, strengthening biopharma services and accelerating drug development capabilities.
Ocugen reports OCU410 Phase 2 data in geographic atrophy, reducing lesion growth and supporting Phase 3 trial in dry age-related macular degeneration.
Amylyx completes Phase 3 trial enrollment for avexitide in post-bariatric hypoglycemia, with Q3 2026 data and potential 2027 launch planned.
Japan approves Dupixent by Regeneron and Sanofi for bullous pemphigoid, improving remission rates in Phase 2/3 trial for autoimmune skin disease.
Novo Nordisk and United Labs report UBT251 Phase 2 data in type 2 diabetes, showing better HbA1c reduction and weight loss than semaglutide.
Oryzon secures USPTO allowance for vafidemstat in borderline personality disorder, strengthening CNS patent protection through 2040.
Takeda announces restructuring to save JPY 200B by 2028, supporting oveporexton, rusfertide and zasocitinib launches and pipeline growth.
Recursion appoints Vicki Goodman as CMO to lead clinical strategy and advance pipeline programs toward key regulatory milestones.
Thermo Fisher and SHL Medical expand Ridgefield to integrate Molly autoinjector with sterile fill-finish for chronic disease drug-device products.
Oragenics reports going concern warning in FY2025 audit under NYSE rules, highlighting financial risk with no changes to prior financial statements.
Artelo expands ART27.13 into GLP-1 therapy to address muscle loss, backed by trial data and a new patent in metabolic and obesity treatment space.
Circio collaborates on circVec RNA therapy for CAR-M targeting cancer, fibrosis, and autoimmune diseases using in vivo delivery approach.
Novo Nordisk gains FDA approval for Awiqli insulin for type 2 diabetes, a once-weekly basal insulin backed by Phase 3 ONWARDS trial results.
Disc Medicine completes Phase 3 APOLLO trial enrollment of bitopertin for erythropoietic protoporphyria, with topline data expected in Q4 2026.
Shuttle Pharma upgrades molecule.ai platform with advanced AI models and autonomous agents to improve drug discovery and candidate selection workflows.
Rhythm Pharmaceuticals receives EMA CHMP opinion for IMCIVREE to treat hypothalamic obesity, with European Commission decision expected in Q2 2026.
Plus Therapeutics appoints industry veteran Ron Andrews to its board, strengthening its leadership with decades of experience in diagnostics and biotech.
ImmunityBio’s Phase 3 QUILT trial meets power criteria, with IDMC confirming no further enrollment needed to assess ANKTIVA + BCG efficacy.
Tonix begins Phase 1 study of TNX-1900 to evaluate trigeminal neurovascular effects, advancing research into migraine-related mechanisms.
Novartis reports Fabhalta slowed kidney decline, cut major risks, and improved proteinuria in final two-year APPLAUSE-IgAN Phase III result
Roche launches cobas MPX-E assay in CE-mark markets, enabling multi-virus blood screening with improved sensitivity and streamlined lab workflows.
Bristol Myers Squibb reports positive Phase 3 results for Camzyos in adolescents with oHCM, showing improved heart function and a strong safety profile.
Praxis gets FDA priority review for relutrigine, a potential first targeted therapy for SCN2A and SCN8A DEEs, with a PDUFA date of Sept 27, 2026.
Transcenta names Dr. Christopher Hwang Head of Global Partnerships to expand HiCB bioprocessing platform through global licensing and strategic collaborations.
Vor Bio begins dosing in the global Phase 3 UPSTREAM SjD trial testing telitacicept for primary Sjögren’s disease, a condition with no approved disease-modifying therapy.
Zymeworks Inc. receives FDA Fast Track for ZW191 in platinum-resistant ovarian cancer, aiming to accelerate development for advanced disease patients.
ACESOT-1051 trial of APR-1051, showing early promise for patients with biomarker-defined solid tumors
Aquestive completes an FDA Type A meeting and plans to resubmit its Anaphylm oral epinephrine NDA in Q3 2026, advancing a first-of-its-kind rescue treatment
Clearmind Medicine completes treatment and follow-up for 18 participants in its Phase I/IIa CMND-100 trial for Alcohol Use Disorder, showing strong safety progress
Immix Biopharma finishes NEXICART-2 enrollment as it prepares topline 2026 results and a BLA for NXC-201, a potential first treatment for AL Amyloidosis.
BridgeBio reports 54-month data showing acoramidis reduces mortality and sustains quality of life in ATTR-CM, reinforcing the benefits of early treatment.
Medicus Pharma reports KOL validation of SkinJect® data, showing strong efficacy in BCC and supporting its potential as a non-surgical treatment option.
GSK’s bepirovirsen NDA accepted in China, showing strong Phase III results and potential to improve low functional cure rates in chronic hepatitis B.
GSK’s Exdensur approved in China for severe asthma, showing strong reduction in exacerbations with just two doses per year in Phase III trials.
Baxter launches IV Verify system to improve IV labelling, reduce medication errors, and enhance nurse efficiency through automated, standardised labelling.
BridgeBio submits FDA NDA for BBP-418, a potential first treatment for LGMD2I/R9, backed by positive Phase 3 results and multiple regulatory designations.
Biogen’s high-dose SPINRAZA was approved by the FDA, showing improved motor function in SMA patients with a new dosing regimen and consistent safety profile.
Acurx secures new Korea patent for DNA Pol IIIC inhibitors, strengthening IP for its antibiotic pipeline targeting drug-resistant Gram-positive infections.
MAIA Biotechnology shows 2+ year overall survival in 8 NSCLC patients in Phase 2 THIO-101 trial after ateganosine and cemiplimab treatment.
Onconetix appoints David White as CEO and adds Sammy Dorf to its Board as the company advances its planned acquisition of Realbotix and prepares for growth.
Proxygen appoints Chiara Conti, Ph.D., as CSO to lead clinical development and advance its molecular glue and proximity-based therapeutics pipeline.
Trethera partners with MGH to test TRE-515 in advanced ALS under FDA Expanded Access for safety and disease tracking.
Serenity Medical’s River™ stent gets FDA approval as the first device for drug-resistant idiopathic intracranial hypertension.
Eli Lilly will buy Centessa Pharmaceuticals to advance orexin agonist therapies for sleep and neurological disorders in a $6.3 billion deal.
Ambros Therapeutics gets USPTO allowance for CRPS-1 patent, boosting IP and neridronate exclusivity through 2045.
Adcytherix starts Phase 1 trial of ADCX-020, expands leadership, and advances its ADC pipeline for global oncology development.
BMS expands Standing in the Gaap program to improve equitable multiple myeloma care, launching a major survey to address gaps in underserved communities.
Efzimfotase alfa shows positive Phase 3 results in hypophosphatasia, improving bone health in children and showing benefits in select adult patient groups.
Biogen to acquire Apellis for $5.6B, adding key complement therapies and boosting revenue growth with approved drugs EMPAVELI® and SYFOVRE®
Agios plans FDA accelerated approval for mitapivat in sickle cell disease, following positive RISE UP data and regulatory guidance on confirmatory trials.
Express Scripts adds CARDAMYST nasal spray to formularies, expanding access to a self-administered treatment for PSVT episodes in the U.S.
Tarsus begins Phase 2 trial of TP-05, an oral therapy designed to prevent Lyme disease by killing infected ticks before transmission.
Thermo Fisher launches Glacios 3 Cryo-TEM, enhancing cryo-EM imaging with AI, improved workflows, and broader lab accessibility.
ORIC reports strong Phase 1b data for rinzimetostat in prostate cancer, selecting 400 mg dose and advancing to Phase 3 Himalayas-1 trial.
Kala Bio brings in Dr. Saeid Babaei as Senior Scientific Advisor to guide AI-driven evaluation of its cell and gene therapy programs and secretome platform.
Oncolytics Biotech completes its move to Nevada and establishes a new U.S. headquarters in San Diego to enhance operations and access to U.S. capital markets
Telix appoints David Gill as Non-Executive Director, with plans for him to transition to Board Chair as part of the company’s leadership expansion.
Zymeworks appoints Kristin Stafford as CFO, bringing strong life sciences, finance, and capital markets expertise to support its strategic growth.
AskBio completes final randomization in its Phase 2 GenePHIT trial for AB-1002, marking key progress in developing new treatment options for HFrEF patients.
AAVantgarde Bio appoints Philip Lao as Senior VP to lead strategic partnerships and support growth in developing therapies for inherited retinal diseases.
Ardelyx names Dr. Rajani Dinavahi as CMO to advance programs in immuno-oncology and nephrology, bringing over 20 years of clinical and biotech experience
Rusan introduces APOSAN 3ml Pen, a portable multi-dose apomorphine device for managing OFF episodes in Parkinson’s disease patients in India.
Lilly wins FDA approval for Foundayo, an oral obesity drug, showing strong weight loss results and expanding access with affordable pricing options.
Thermo Fisher launches CHOvantage GS platform to speed biologics development with high yields, faster timelines, and royalty-free licensing.
Vertex gains FDA approval to expand ALYFTREK and TRIKAFTA use, enabling more cystic fibrosis patients to access CFTR-modulating treatments.
Ocugen completes dosing early in Phase 2/3 trial of OCU410ST gene therapy for Stargardt disease, with BLA submission planned for 2027.
AstraZeneca’s EMERALD-3 trial shows improved PFS with Imfinzi-based combo in liver cancer, with early signs of survival benefit.
Merck launches Phase 2b/3 MALBEC trial for MK-8748 in wet AMD, advancing its ophthalmology pipeline targeting retinal diseases.
Merck’s KEYTRUDA gains EU approval for platinum-resistant ovarian cancer, showing improved survival as the first PD-1 therapy for this group.
Context’s CTIM-76 gains FDA Fast Track for platinum-resistant ovarian cancer, accelerating development of its bispecific antibody therapy.
CellCarta and Pillar Biosciences partner to streamline NGS tumour profiling, enabling faster, cost-efficient, biomarker-driven oncology trials.
Oncotelic and TechForce partner to commercialise AI-powered GMP robotics, enhancing automation, compliance, and efficiency in pharmaceutical manufacturing.
Thermo Fisher launches automated CTS Compleo system to streamline cell therapy fill-finish, reducing variability and improving GMP-compliant manufacturing.
Regeneron partners with TriNetX to integrate genomic and health data, accelerating drug discovery and advancing AI-driven digital health solutions.
Revolution Medicines begins global Phase 3 RASolute 303 trial testing daraxonrasib alone and with chemo for metastatic pancreatic cancer.
FDA approves longer dosing intervals for EYLEA HD, allowing some wet AMD and DME patients to extend treatment to every 20 weeks.
BARDA awards Vericel a 10-year, $197M contract to support NexoBrid supply, emergency readiness, and future development
FDA grants Fast Track status to CDI-988, Cocrystal’s oral antiviral aimed at preventing and treating norovirus infections.
Biodexa teams with Syngene to manufacture MTX240 API and dosage form as it prepares for IND filing and upcoming clinical trials.
BioCardia submits CardiAMP HF trial data to the FDA as it seeks potential accelerated approval for its heart failure therapy.
Annovis Bio secures a U.S. patent for buntanetap to prevent and treat brain injuries caused by infections, strengthening its neurodegenerative drug program.
Revolution Medicines begins global Phase 3 RASolute 303 trial testing daraxonrasib alone and with chemo for metastatic pancreatic cancer
Denali Therapeutics takes full control of DNL593 as Takeda ends collaboration; Phase 1/2 trial results expected by end of 2026, strategic decision not data‑based.
Rhythm Pharmaceuticals welcomes Kim Popovits to its Board as Ed Mathers steps down, bringing decades of life sciences and commercialization expertise
Pharma Now's Voices of Pharma podcast features Shyam Khante (ex-GSK Technical Director) sharing 5 leadership pillars, judgment, urgency, enthusiasm, people care, humor.
Organogenesis confirms FDA Type-B meeting outcome, moving forward with rolling BLA submission for ReNu to treat knee osteoarthritis before December 2026.
Renovare Therapeutics emerges from stealth, partnering with CU Boulder with ARPA-H funding to advance regenerative osteoarthritis therapies and clinical trials.
Silo Pharma announces EPO’s intent to grant a patent for its 5-HT4 agonist approach, targeting stress prevention & resilience through innovative CNS therapies.
Organogenesis to build a $100M facility in Smithfield, RI, boosting wound care and regenerative medicine production and creating over 200 jobs.
Akari Therapeutics forms strategic partnership with WuXi XDC to accelerate development of its PH1 ADC payload, advancing AKTX-101 toward future clinical trials.
Ascendis Pharma receives FDA orphan drug exclusivity for YUVIWEL and makes it commercially available in the U.S., supporting children with achondroplasia.
Avicanna announces John McVicar’s resignation and welcomes Ozgur Kilic to its Board, bringing extensive global pharma and leadership experience to the company.
Neuronetics announces CFO Steven Pfanstiel’s resignation, continuing through May 2026 to ensure a smooth transition and support business continuity.
Chugai and Osaka University identify new ITP subgroup and simple test, enabling targeted treatment with complement inhibitors in blood disorder patients.
IDEAYA enrolls first patient in Phase 1 trial of IDE574, a dual KAT6/7 inhibitor showing strong preclinical anti-tumor activity in solid cancers.
Medicus submits optimized Phase 2 trial design for Teverelix to FDA, targeting the prevention of recurrent urinary retention in BPH patients.
ImmunityBio responds to FDA OPDP concerns, removes podcast, and strengthens compliance for ANKTIVA promotions while clarifying scientific statements.
Praxis reports positive EMBRAVE trial results, with elsunersen showing strong seizure reduction and safety in children with SCN2A epilepsy.