Pharma News, 2022

Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced positive topline...

Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has informed the Company that it does not plan to hold ...

Korea’s antitrust regulator has fined AstraZeneca and Korean generics company Alvogen a combined $1.82 million for colluding to avoid competition.

Gilead Sciences and MacroGenics entered into a licensing and collaboration pact worth up to $1.7 billion to develop a bispecific antibody to treat hematological cancers. This comes only two months ...

Among the slate of decisions from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) October meeting came good news for Takeda.  ...

Helsinn Healthcare has decided to withdraw its New Drug Application (NDA) of Truseltiq (infigratinib) and permanently discontinue U.S. distribution of the drug, which had been granted accelerated F...

The FDA has accepted BioMarin Pharmaceutical’s resubmission of a Biologics License Application (BLA) for its  investigational adeno-associated virus (AAV) gene therapy valoctocogene roxaparv...

China-based RemeGen has received FDA’s Orphan Drug designation for its investigational drug telitacicept for patients with myasthenia gravis, a chronic autoimmune disease which causes muscle wea...

Bayer’s quest to revamp its drug discovery engine continues apace, with the company’s recently acquired Vividion subsidiary forging an alliance with Tavros Therapeutics, aimed at finding new dr...

Merck has decided to exercise its option to develop and commercialize the personalized cancer vaccine (PCV) mRNA-4157/V940 with Moderna.

Rigel Pharmaceuticals decided to not file a supplemental New Drug Application (sNDA) for fostamatinib in the treatment of patients with warm autoimmune hemolytic anemia, an autoimmune disorder tha...

The FDA has granted Priority Review to Regeneron’s supplemental Biologics License Application (sBLA) for its blockbuster drug Eylea (aflibercept), as an injection in the proposed treatment for pr...