The U.S. government has agreed to buy 1.5 million more doses of Novavax Inc. COVID-19 vaccine, the company said on Monday, adding that the modified agreement includes funds for development of an updated vaccine by fall this year.
Tag Archive for: U.S. Food and Drug Administration (FDA)
Blueprint Medicines Corp. said on Friday the U.S. drug regulator had put on partial hold an early-stage trial testing its experimental cancer drug due to safety concerns, sending its shares down nearly 6%.
It was a good Thursday for GSK’s Jemperli (dostarlimab), as the immunotherapy received both full FDA approval in endometrial cancer and the regulatory go-ahead regarding its development plan in rectal cancer.
The FDA has set a Feb. 9 meeting for its Oncologic Drugs Advisory Committee (ODAC) to discuss whether GSK’s clinical development plans for Jemperli (dostarlimab) could support accelerated approval.
Biogen’s $1.5 billion bet is in the home stretch. On Monday, the Cambridge biotech, along with partner Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
The FDA put 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced February 2.
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 U.S. Food and Drug Administration has warned against using an India-made eye drop that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients including infections, blindness and one death.
The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc’s drug as the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.
The U.S. Food and Drug Administration (FDA) said on Tuesday it will restructure its food program that was slammed last year for responding too slowly to an outbreak of illness among infants who consumed formula from an Abbott Laboratories production plant.
