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…
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…
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 European Medicines Agency’s (EMA) human medicines committee has endorsed eight new drugs for approval following its February monthly meeting. Source: Drug Industry Daily
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outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance.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
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…
Senators Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) want Merck to slow down its Keytruda patent juggernaut. Source: Drug Industry Daily
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
The number of drug applications that the FDA has received involving artificial intelligence (AI) and machine learning (ML) tools jumped from just a handful before the COVID-19 pandemic to more…