FDA

Thursday, the FDA selected Moderna Inc’s (NASDAQ:MRNA) mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency....

A committee of advisors to the U.S. Food and Drug Administration (FDA) dealt a blow to the burgeoning field of psychedelic medicine by recommending against the approval of MDMA-assisted therapy as a treatment for PTSD. MDMA, also known as ecstasy, has been studied for over a decade as a potential...

The Federal Trade Commission (FTC) is intensifying its efforts to challenge numerous pharmaceutical patent listings, aiming to facilitate the availability of more affordable alternatives to brand-name drugs, including blockbusters like Novo Nordisk A/S’s (NYSE:NVO) Ozempic...

The FDA granted accelerated approval on Thursday to Madrigal Pharmaceuticals Inc.’s (NASDAQ:MDGL) Rezdiffra (resmetirom) noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis) to be used along with diet and exercise.  Continued...

The Centers for Medicare and Medicaid Services (CMS) is considering the inclusion of Novo Nordisk’s (NYSE:NVO) obesity drug Wegovy in its coverage for heart disease patients with obesity. What Happened: The CMS is reviewing the FDA's action to expand the use of Wegovy to reduce the risk of...

The credibility of the clinical trial results for an experimental Alzheimer’s drug has been called into question following a critical inspection report by the Food and Drug Administration (FDA). What Happened: The FDA report, which was released under the Freedom of Information Act,...

Expressing concern that President Joe Biden might backtrack on a proposal to avoid backlash from Black voters, a senior health official in the Biden administration is encouraging allies outside the government to press the White House to enact a nationwide ban on menthol cigarettes. Robert Califf,...

During a recent hearing on vaccine safety, Rep. Marjorie Taylor Greene (R-Ga.) made controversial statements that have drawn criticism from her Democratic colleagues. What Happened: Greene, who is not a medical professional, said, "I'm not a doctor, but I have a Ph.D. in recognizing bulls*...

NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) shares are trading higher Thursday after the company announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726 for the treatment of obesity. The Details: NeuroBo announced that the FDA has...

Following a preliminary review, the U.S. Food and Drug Administration found no evidence that weight-loss drugs cause suicidal thoughts. What To Know: Following reports of suicidal thoughts or actions, the FDA conducted a review of a class of popular weight-loss and diabetes drugs known as GLP-1 RAs...

A massive recall of hypoallergenic infant formula has been initiated due to concerns over potential bacteria contamination. The recall involves approximately 675,000 cans of infant formula. What Happened: Reckitt Benckiser Group plc‘s (OTC:RBGLY) Mead Johnson Nutrition (NYSE:MJN) is...

Logan Paul, the YouTube influencer turned WWE Superstar and co-founder of PRIME, came forward on Thursday in defense of the drink amid mounting criticism and possible government intervention. What Happened: PRIME drinks shot to fame among teens immediately upon the brand’s release, and...

Elon Musk's brain-implant company Neuralink has received the green light from the Food and Drug Administration to commence its "first-in-human clinical study." What Happened: This milestone achievement for Neuralink comes after a series of setbacks and challenges faced by the company in its pursuit...

U.S. markets closed mixed on Monday as investors and traders commenced the week on a cautious note ahead of the release of the consumer price inflation data on Wednesday that will decide the course of the Federal Reserve's next policy decision. What Happened: The Nasdaq Composite closed 0.03%...

Despite concerns about potential animal-welfare violations, Elon Musk-led Neuralink is searching for a suitable partner to conduct human clinical trials of its brain-implanted chips.  What Happened: Neuralink, a brain implant firm, has reached out to Barrow Neurological Institute, one of the...