Food and Drug Administration

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...

Michael Pollan, the celebrated food reform advocate, stirred controversy this week after sharing an article on Robert F. Kennedy Jr. in The American Conservative. In a recent interview with Politico, Pollan discussed the nuances of his views on RFK Jr., especially when it comes to Kennedy's stance...

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...

In a key regulatory milestone, Ispire Technology Inc. (NASDAQ:ISPR), a leading company in design, development and commercialization of vaping products, and its joint venture with IKE Tech LLC have made strides towards a Pre-Market Tobacco Product Application (PMTA) for novel Identity and Age...

A new study published in Scientific Reports revealed that while U.S. healthcare professionals are largely open to the therapeutic potential of psychedelics like psilocybin and MDMA, their understanding of their clinical uses and risks is limited. The research, led by Erin Wang and colleagues from...

Massachusetts voters decisively rejected Question 4, a ballot measure proposing the legalization and regulation of certain psychedelics, including psilocybin, mescaline, DMT and ibogaine, for therapeutic use. With 90% of votes counted, Question 4 was defeated with a 56.9% "No" vote, marking a...

Federal agencies recently convened in a pivotal public meeting, hosted by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), to discuss emerging treatments for post-traumatic stress disorder (PTSD), with a focus on the potential of psychedelics. As Lexology reported, the...

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-...