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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 cancer patients treated with AA drugs. Read More
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 for finished products and other lapses. Read More
The European Medicines Agency’s (EMA) human medicines committee has endorsed eight new drugs for approval following its February monthly meeting. Read More
The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. Read More
The plaintiffs are seeking injunctions against the generics makers barring them from marketing alternatives to Yupelri until the expiration of patent protections, as well as damages. Read More
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. Read More
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). Read More
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 left the door open to reconsidering the idea in the future. Read More
Lagevrio is under Emergency Use Authorization for the treatment of mild-to-moderate COVID-19 adult patients who are at high risk of progression to severe COVID-19.