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

The FDA on Friday approved an intravenous formulation of Novartis’ IL-17A antagonist Cosentyx (secukinumab) for the treatment of rheumatic diseases.

The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the company should conduct additional risk testing.

The FDA has placed a partial clinical hold on two of Innate Pharma’s trials assessing its investigational antibody lacutamab following one patient death, the company announced Thursday

Amgen’s regulatory ambitions for its non-small cell lung cancer drug Lumakras (sotorasib) ran into headwinds Tuesday, after FDA staff indicated in their briefing document that there might not be sufficient evidence of its efficacy to justify full approval.

Eli Lilly and Co. on Wednesday appointed a new chief for its diabetes and obesity unit in a string of leadership changes ahead of a key regulatory decision on the use of its potential blockbuster drug Mounjaro as a weight-loss treatment.

The U.S. Food and Drug Administration said on Tuesday it authorized an updated version of Novavax’s COVID-19 vaccine for emergency use in individuals aged 12 years and older, and the company’s shares closed 8% higher.

The U.S. Food and Drug Administration’s staff reviewers said on Tuesday that Amgen’s late-stage study may not provide enough evidence of effectiveness for its lung cancer drug, as the company pursues a traditional approval for the treatment.

The U.S. Food and Drug Administration (FDA) has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1).

The FDA has rejected Eli Lilly’s investigational antibody lebrikizumab for the treatment of moderate-to-severe atopic dermatitis due to manufacturing problems, the company announced on Monday.

Tonix Pharmaceuticals Holding Corp. said on Tuesday its experimental drug failed to meet the primary goal in a mid-stage study for management of widespread muscle pain and tenderness associated with long COVID-19.