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Mar 08, 2026
More than 16,000 dermatology trials were completed, ongoing, or planned by the end of 2025, with the Asia-Pacific region experiencing a nearly five-fold increase over the past decade. The field now accounts for around 8,000 trials in Asia-Pacific alone, matching North America and Europe combined.
Mar 08, 2026
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
Mar 07, 2026
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
Mar 06, 2026
Dyne Therapeutics is preparing a U.S. Accelerated Approval submission for z-rostudirsen in Duchenne muscular dystrophy and gearing up for a Phase 3 trial of z-basivarsen in myotonic dystrophy, while scaling operations to support potential commercialization.
Mar 05, 2026
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
Mar 05, 2026
Affinia Therapeutics has received FDA fast track designation and EMA orphan drug designation for AFTX-201, an investigational gene therapy for BAG3-associated dilated cardiomyopathy, a rare genetic heart disease affecting over 70,000 patients.
Mar 05, 2026
The large molecule drug substance CDMO market is expected to grow at approximately 9% CAGR through 2031, driven by rising demand for biologics and biosimilars, streamlined regulatory approval pathways, and increasing FDA and EMA approvals for biologic therapies.
Mar 03, 2026
Acurx Pharmaceuticals will discuss full year and fourth quarter 2025 financial results on March 13, 2026, and provide updates on ibezapolstat, its lead antibiotic candidate preparing for international Phase 3 trials for C. difficile infection.
Mar 04, 2026
Scholar Rock plans to resubmit its biologics license application for apitegromab in spinal muscular atrophy following FDA reinspection of the Catalent Indiana fill-finish facility, with a U.S. launch anticipated in 2026.
Mar 03, 2026
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
Mar 03, 2026
Ocugen has completed enrollment of 140 patients in its Phase 3 liMeliGhT trial for OCU400, a gene therapy for retinitis pigmentosa. Topline data expected in Q1 2027 could support potential approval later that year.
Mar 02, 2026
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
Mar 02, 2026
The pharmaceutical industry is experiencing recovery driven by innovation in drug development, aggressive M&A activity, and expansion of drug development services. The sector faces both opportunities and headwinds including pipeline setbacks and regulatory pressures.
Mar 01, 2026
Cogent Biosciences presented additional SUMMIT trial data showing bezuclastinib achieved 56% improvement in symptoms at 48 weeks in NonAdvSM patients, with multiple regulatory submissions advancing toward expected commercial launch in second half of 2026.
Feb 28, 2026
Sanofi receives FDA approval for Dupixent to treat allergic fungal rhinosinusitis and gains European endorsement for Acoziborole Winthrop as a sleeping sickness treatment, which will be donated to WHO.
Feb 27, 2026
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Feb 23, 2026
The FDA has filed Savara's biologics license application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a target action date of August 22, 2026.
Feb 21, 2026
ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.
Feb 20, 2026
The European Commission has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults with obesity, providing physicians with an additional treatment option for patients requiring further weight reduction after the 2.4 mg dose.
Feb 26, 2026
Orphan drug development faces structural uncertainty due to small patient populations and varying global definitions, with regulators balancing early access against evidence requirements through accelerated pathways and post-market monitoring.
