Multiple doses of Eli Lilly’s top-selling diabetes medication Mounjaro (tirzepatide) will be in short supply through April 2024, according to the FDA’s database for drug shortages and discontinuations.
Verve Therapeutics has suspended enrollment in the Phase Ib Heart-1 study evaluating its lead gene editing program VERVE-101 following a serious adverse event, the company announced Tuesday.
The U.S. Food and Drug Administration (FDA) has approved Abbott’s first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that’s specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve.
The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.
The FDA is planning to increase its inspection of drug manufacturing facilities in India this year amid growing quality and supply concerns, Reuters reported Tuesday citing an agency executive.
The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.
The attorney general for one of the most populous U.S. states this week urged federal drug regulators to address safety risks associated with the widely used asthma and allergy medicine Singulair, saying current warnings on the drug’s packaging are insufficient, particularly for children.
The FDA has granted Priority Review to Sanofi and Regeneron’s supplemental Biologics License Application seeking to expand its blockbuster antibody therapeutic Dupixent (dupilumab) into chronic obstructive pulmonary disease, the companies announced Friday.
With drug shortages in the U.S. not greatly improving, the Federal Trade Commission and the Department of Health and Human Services announced Wednesday that they are issuing a request for information to look at different groups involved in generic drug supply chains and evaluate how they may be contributing to persistent shortages.
ReutersThe U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson unit Actelion Pharmaceuticals’ injection, making it the first-ever treatment to treat severe frostbite in adults.
