Lilly

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.

FDA

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.

FDA

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.

Takeda

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.

Novartis

The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis.

Pfizer

The U.S. Food and Drug Administration on Monday approved Pfizer’s (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies.

The FDA has established a voluntary pilot program intended to address the risks when targeted cancer treatments are approved without a companion diagnostic.