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The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. 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
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 than 120 in 2021 and topped 150 in 2022.
HHS has published a subset of its semiannual rulemaking agenda for 2023, outlining those planned rules – including several from the FDA – that are likely to have a significant economic impact for some small entities.
Baudette, Minn.-based Ani Pharmaceuticals was hit with a six-observation Form 483 from the FDA that spotlights almost a year of ignoring customer complaints about products and not following its standard operating procedures (SOPs) for handling events that set off alarms in production.