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 (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.
The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its developer ARS Pharmaceuticals down 47% premarket.
Sage Therapeutics said on Thursday it plans to lay off about 188 people, or about 40% of its workforce, weeks after the U.S. health regulator declined to approve its drug to treat major depressive disorder.
The FDA has approved many different generic versions of Takeda’s blockbuster Vyvanse (lisdexamfetamine dimesylate), used for the treatment of attention-deficit/hyperactivity disorder and binge-eating disorder in adults.
The U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers, ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, reflecting findings from FDA inspections of these facilities over the last several months.
The FDA on Wednesday rejected Outlook Therapeutics’ investigational ophthalmic bevacizumab solution ONS-5010, which the company was proposing as a treatment for wet age-related macular degeneration.
the Digital Medicine Society (DiMe) released findings from a digital health industry needs assessment to identify 1) the drivers of successful digital health product development and adoption, and 2) the regulatory policy needed to facilitate these drivers.
