Tag Archive for: U.S. Food and Drug Administration (FDA)

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.

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.

AstraZeneca announced Monday that it has secured FDA approval for an add-on to its blockbuster rare disease franchise, providing a potential differentiator as it tries to hold off competition from Novartis, Roche, and biosimilars.

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.

AstraZeneca on Monday shut down the bulk of its roxadustat partnership with FibroGen, returning the rights to develop and commercialize the investigational HIF-PH inhibitor in the U.S. and other AstraZeneca territories to the biotech.

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.

Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.

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.

BioSpace

While Otsuka Pharmaceutical can expect to a drop in sales as its schizophrenia therapy Abilify Maintena (aripiprazole) loses its market exclusivity later this year, the recently approved longer-acting formulation Abilify Asimtufii will help the company buttress its revenues, according to a report Wednesday from data analytics and consulting firm GlobalData.