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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.
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.
ANDA applicants should submit a request for a PSG teleconference within 60 days after publication of a new or revised PSG so that the FDA can provide timely feedback, the agency said. Read More
The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection to treat patients with geographic atrophy secondary to age-related macular degeneration, a condition that is a leading cause of blindness. Read More