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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.
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.
