The FDA has approved Gamida Cell’s omidubicel-onlv, now to be marketed as Omisirge, in patients over 12 years of age with blood cancers, the company announced Monday.

The U.S. Food and Drug Administration on Tuesday authorized a second dose of Omicron-targeting COVID-19 vaccines for older adults as well as those with a weak immune system.

Sarepta Therapeutics Inc.’s shares fell more than 6% on Thursday as Stat News reported that the U.S. health regulator’s staff were inclined to reject the company’s gene therapy which is currently under review.

Merck KGaA said on Wednesday the U.S. Food and Drug Administration (FDA) had paused the initiation of new patients on its multiple sclerosis evobrutinib drug, knocking the German drugmaker’s share price.

Abortion opponents on Tuesday urged a U.S. appeals court to allow the suspension of Food and Drug Administration’s approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the government regulates medicine.

Biopharma rallies behind FDA after Texas abortion pill ruling Published: Apr 11, 2023 By Tristan Manalac BioSpace In an open letter published Monday, more than 480 biopharma industry leaders, including […]

The U.S. government on Monday appealed a Texas judge’s decision to suspend the Food and Drug Administration’s 23-year-old approval of a key abortion drug, saying the ruling endangered women’s health by blocking access to a pill long deemed safe.

The U.S. Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer’s drug developed by Eisai Co. Ltd. and Biogen Inc. according to a federal filing on Monday.

A federal judge’s decision last week to suspend the U.S. Food and Drug Administration’s (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said.

The White House is planning to re-up discussions with abortion pill manufacturers and U.S. pharmacy chains on ways to push back against efforts to ban mifepristone, two sources with knowledge of the matter said, as it appeals a Texas court ruling suspending the approval of the drug.