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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
Theravance Biopharma and Viatris have alleged that multiple drugmakers infringed on their patent protections for Yupelri (revefenacin) — an inhalation solution used to treat chronic obstructive pulmonary disease (COPD) — by developing generic versions of the drug. Read More
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 the rare kidney disease primary endothelin-1 and angiotensin II (IgAN). Read More
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 monoclonal antibodies used to treat the disease, according to a report by the Institute for Clinical and Evidence Review (ICER). Read More
The FDA required a boxed warning with the product that some patients treated with Lamzede have experienced hypersensitivity reactions, including anaphylaxis. Read More
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. Read 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 DL Chesney Consulting. Read More