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…
A bipartisan group of 20 U.S. senators has called for federal coverage of antiamyloid antibodies approved to treat Alzheimer’s disease. Source: Drug Industry Daily
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…
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…
Drugmakers may need to consult with their legal counsel during an FDA inspection so they know what the agency may legally request, according to inspection expert David Chesney, principal of…
The FDA has released new details for companies preparing to submit an abbreviated new drug application (ANDA) on how to request meetings relating to a new or revised product-specific guidance…
The FDA is considering asking Congress for enhanced authority over opioid approvals and marketing to ensure that new products offer “material safety advantages” over existing approved opioid analgesics. Source: Drug…
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. Source:…
TG Therapeutics would have to cut the price of its newly approved multiple sclerosis antibody Briumvi (ublituximab) by up to 84 percent to meet the same cost-effectiveness threshold as other…
The FDA has granted Accelerated Approval (AA) to Travere Therapeutics’ Filspari (sparsentan) to reduce proteinuria (high levels of protein in the urine) in adults at risk of rapid progression of…