Food and Drug Administration

ImmunityBio Inc (NASDAQ:IBRX) shares were up during Monday’s premarket session, but dipped as the company addresses compliance issues raised by the U.S. Food and Drug Administration (FDA). The FDA issued a warning to ImmunityBio, alleging that the company made unsupported claims that Anktiva...

Dr. Vinay Prasad, head of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), which oversees vaccines and biotech drugs, is set to leave his position at the end of April, FDA Commissioner Marty Makary confirmed on Friday. Prasad Exits FDA After...

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.’s (NASDAQ:NVAX) COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase the risk of severe illness. What Happened: The decision follows a...

U.S. Health Secretary Robert Kennedy Jr. praised the Food and Drug Administration’s decision to begin removing fluoride supplements for children from the market, calling the move “long overdue.” What Happened: The FDA announced on Tuesday that it’s initiating a process to...

The U.S. Food and Drug Administration announced a major shift in how monoclonal antibody therapies and other drugs are evaluated, emphasizing a transition from traditional animal testing. The agency aims to adopt human-relevant and technologically advanced testing methods to improve safety...

The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.’s (NASDAQ:APLS) supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex...

On Monday, Glaukos Corporation (NYSE:GKOS) received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for Epioxa (Epi-on), its next-gen corneal cross-linking iLink therapy for keratoconus, a...

The Food and Drug Administration on Tuesday approved Ozempic, the weight loss drug made by Novo Nordisk A/S (NYSE:NVO), for the treatment of chronic kidney disease in patients who also have type 2 diabetes.  The Details: According to the Centers for Disease Control and Prevention, more than 35.5...

The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA’s (NASDAQ:SNY) Genzyme Corporation regarding significant violations at its Framingham, Massachusetts, facility. After an inspection conducted between June 12 and July 9, 2024 the agency flagged major concerns...

The U.S. Food and Drug Administration announced a ban on Red No. 3, an artificial food coloring linked to cancer in animal studies, effective Jan. 15, 2027. The dye, found in products ranging from candy to cold medicine, has been scrutinized for decades. This move follows the FDA's 1990...

Robert F. Kennedy Jr. is a vocal opponent of artificial food dyes, blaming them in part for the “chronic disease epidemic" in America. He may get the opportunity to bring major changes to the U.S. food industry under the incoming Trump administration.  What To Know: President-elect...

Former President Donald Trump has pledged to give Robert F. Kennedy Jr. full authority over health, food, and medicine issues if he secures a second term. What Happened: Trump revealed his plans on Sunday, expressing his intent to allow Kennedy to have free reign over health, food, and medicine-...

In response to an E. coli outbreak associated with fresh onions, leading U.S. fast-food chains including McDonald’s Corp (NYSE:MCD), Restaurant Brands International (NYSE:QSR), and Yum Brands Inc. (NYSE:YUM) have decided to remove the vegetable from their menus. The outbreak has reportedly...

Novo Nordisk (NYSE:NVO) has appealed to the U.S. Food and Drug Administration (FDA) to halt the production of compounded versions of its drugs Wegovy and Ozempic by compounding pharmacies. These cheaper alternatives have been under scrutiny due to potential safety risks and lack of FDA approval....

Antivaccine advocate and former independent presidential candidate, Robert F. Kennedy Jr., stated that he might be appointed by former President Donald Trump to select leaders for key public health agencies, should the former president win a second term. What Happened: Kennedy Jr. disclosed this...