Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai.
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma's rival antibody tralokinumab.
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year.
The FDA has approved AstraZeneca and Amgen's severe asthma hope tezepelumab, exonerating the drugmakers' decision to press ahead with a regulatory filing despite a failed phase 3 trial.
Bristol-Myers Squibb's rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transpl
