The agency’s briefing documents highlighted increased risk of diabetes and liver injury from using the obeticholic acid oral tablets for treatment of nonalcoholic steatohepatitis.
Tag Archive for: FDA
The justices turned away Israel-based Teva’s appeal of a lower court’s ruling reinstating the jury award for U.K.-based GSK. The case involves “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug’s label omits potentially infringing uses of a brand-name drug.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
Veozah, an oral once-daily medication, is the first FDA-approved NK3 receptor antagonist for hot flashes, a common symptom of menopause that can affect health and quality of life.
Shares of Sarepta Therapeutics soared 29% premarket on Monday as a backing by the U.S. health regulator’s advisers increased the certainty of an accelerated approval for the company’s gene therapy for a muscle-wasting genetic disorder.
Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.
The potential one-time treatment is the first gene therapy for the rare muscle-wasting disorder to reach the FDA’s doorstep, and could change the way patients with the disease are treated if approved.
The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.
Colchicine, a drug used to treat gout, saw a 16-fold price increase since the FDA changed its policy toward single-ingredient oral colchicine products, which had previously been available generically.
The health regulator flagged application deficiencies related to the FDA’s pre-license inspection of the company’s third-party contract manufacturing firms.
