Pharma News

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...

Aptar Pharma has added another element to its suite of digital support tools for patients as they make their journey through the healthcare system.

The FDA has granted Eligo Bioscience Orphan Drug and Rare Pediatric Disease designations for its investigational gene therapy EB003 for treating patients with Shiga-toxin producing bacterial infec...

A compound that both inhibits the MRSA superbug and renders it more vulnerable to antibiotics has been discovered by scientists at the University of Bath led by Dr. Maisem Laabei and Dr. Ian Blagbr...

The FDA has accepted Gilead Sciences’ supplemental Biologics License Application (sBLA) of Trodelvy (sacituzumab govitecan-hziy) for Priority Review in treating patients with unresectable locall...