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Feb 26, 2026
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
Feb 25, 2026
Cellectar Biosciences said it will report full-year 2025 financial results and provide a corporate update on March 4, 2026. The company also shared conference call, webcast, and replay details.
Feb 24, 2026
Novo Nordisk plans to slash U.S. list prices for Wegovy and Ozempic by up to 50% starting January 2027, while securing European Commission approval for a new 7.2 mg dosage of Wegovy.
Feb 23, 2026
Benitec Biopharma will present interim clinical study results for BB-301 gene therapy in oculopharyngeal muscular dystrophy patients at the Muscular Dystrophy Association Conference on March 9, 2026, including 12-month and 24-month follow-up data.
Feb 17, 2026
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
Feb 17, 2026
Novo Nordisk secured FDA approval for oral Wegovy tablets in December 2025 and subsequently sued telehealth company Hims & Hers for patent infringement over compounded versions. The company is the only manufacturer with an FDA-approved GLP-1 weight loss pill.
Feb 13, 2026
Major pharmaceutical companies are highlighting their drug pipelines to offset upcoming patent losses, while Moderna confronts FDA rejection of its flu vaccine. The industry faces significant revenue challenges from patent cliffs in 2026.
Feb 21, 2026
Savara Inc. announced the FDA has accepted its Biologics License Application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a PDUFA action date of August 22, 2026.
Feb 16, 2026
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
Feb 21, 2026
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
Feb 19, 2026
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
Feb 19, 2026
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
Feb 18, 2026
European regulators approved a 7.2mg "megadose" of Novo Nordisk's Wegovy involving three weekly injections. The Danish drugmaker filed suit against Hims & Hers after the telehealth company briefly launched a compounded oral semaglutide product.
Feb 19, 2026
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
Feb 18, 2026
ImmunityBio's stock jumped 41.9% following the European Commission's conditional marketing authorization for Anktiva combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer across 33 European countries.
Feb 18, 2026
The European Commission has authorized a new 7.2 mg once-weekly dose of Wegovy (semaglutide) for adults with obesity across all 27 EU member states, following positive opinion from the EMA's scientific committee in December 2025.
Feb 18, 2026
Rezon Bio's Warsaw-Duchnice facility has received FDA approval for commercial manufacturing of a biosimilar, following previous EMA GMP certification for European markets.
Feb 18, 2026
Moleculin Biotech announced a preliminary blinded composite complete remission rate of 40% in the first 30 subjects of its Phase 2B/3 MIRACLE trial testing Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia.
Feb 18, 2026
BioArctic reported net revenues of SEK 184.0 M for Q4 2025, driven by Leqembi royalties and Novartis partnership income. Leqembi received multiple regulatory approvals and submissions across global markets during the quarter.
Feb 17, 2026
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
