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 U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly and partner Boehringer Ingelheim’s drugs Jardiance and Synjardy to treat type 2 diabetes in children.
The FDA has approved Lexicon Pharmaceuticals’ sotagliflozin, now to be marketed as Inpefa, as a once-daily oral medication to cut the risk of cardiovascular death and heart failure admissions and visits in adult patients with underlying heart failure, the company announced Friday.
The U.S. Food and Drug Administration has approved GSK Plc’s respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people.
The FDA has approved Pfizer’s Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine) for use in infants and children from six weeks to 17 years of age, the company announced Thursday.
Brussels on Wednesday published a long-awaited draft of its proposed overhaul of laws governing the European Union’s pharmaceuticals industry, setting up a tussle with drugmakers which warn they will invest and innovate elsewhere.
The agency’s decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from rivals such as Abbvie, Pfizer, and Johnson & Johnson.
Shares of Reata Pharmaceuticals Inc. soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future.
Gilead Sciences Inc. said on Friday the U.S. Food and Drug Administration had greenlighted expanded use of Trodelvy to treat the most common type of breast cancer, marking the third approval for the drug.
The FDA greenlit AstraZeneca’s anti-CTLA-4 antibody tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.