Cosmoceutical Research Center was hit with a five-observation Form 483 following an inspection of its Panorama City, Calif., facility for lack of written quality control procedures, failing to test incoming…
The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. Source: Drug Industry Daily
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…
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