The European Medicines Agency’s (EMA) human medicines committee has endorsed eight new drugs for approval following its February monthly meeting. Source: Drug Industry Daily

ALI Pharmaceutical, a drug intermediate and active pharmaceutical ingredient (API) manufacturer in Omaha, Neb., was hit with a Form 483 for microbial contamination of products, failure to establish microbiological specifications…

The FDA should move more quickly to withdraw its approval of drugs granted Accelerated Approval (AA) when negative confirmatory trial data emerge, said members of a research team that studied…

The FDA will soon announce a new pilot program to help developers of gene therapies for rare diseases get their treatments approved faster, said Peter Marks, director of the FDA’s…

A single infusion of BioMarin’s Roctavian (valoctocogene roxaparvovec) reduced bleeding rates by 84 percent for two years in patients with hemophilia A, according to a study published in The New…

Attorneys general from a dozen states have filed a lawsuit against the FDA over its Risk Evaluation and Mitigation Strategies (REMS) for the abortion pill, mifepristone, arguing that the restrictions are…

AstraZeneca has announced plans to extend its oncology drug portfolio through a licensing deal with KYM Biosciences for an investigational antibody-drug conjugate (ADC) for treatment of gastric cancer. Source: Drug…

In another Alzheimer’s disease therapeutics payment slapdown, the Centers for Medicare and Medicaid Services (CMS) rejected a petition by the Alzheimer’s Association to expand coverage of antiamyloid antibody therapy, but…

The FDA has granted Fast Track designation to Icosavax’s IVX-A12, an innovative investigational bivalent vaccine that targets both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Source: Drug Industry Daily

Senators Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) want Merck to slow down its Keytruda patent juggernaut. Source: Drug Industry Daily