The Latest Breaking News from FDA

Gilead's Newly Approved HIV Prevention Drug Poised To Add Billions To Future Sales

In June, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc.'s (NASDAQ:GILD) Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the U.S. for people who need or…

Benzinga · Jul 25, 2025

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).

Benzinga · Jul 25, 2025

Eli Lilly's Early Alzheimer's Drug Recommended For Approval By European Drug Regulator's Panel

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday recommending Eli Lilly and Co.’s (NYSE:LLY) donanemab for early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.

Benzinga · Jul 25, 2025

The Truth About “Organic”: 8 Common Kid Snacks With Dangerous Allergens

Image source: 123rf.com

Kids Ain't Cheap · Jul 24, 2025

15 Best Vagus Nerve Stimulation Devices in 2025

Stress and sleepless nights can wear anyone down

inkl · Jul 24, 2025

Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revise Label

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced Monday it will voluntarily and temporarily pause all U.S. shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, effective July 22.

Benzinga · Jul 23, 2025

What's Going On With Moderna Stock Wednesday?

Moderna Inc.’s (NASDAQ:MRNA) stock has surged approximately 37% in the last month but has dipped around 15% year to date.

Benzinga · Jul 23, 2025

Americans Are Turning To DIY Weight Loss Injections to Dodge $1,000+ Monthly Drug Costs

Demand for glucagon-like peptide-1 weight-loss drugs — such as Ozempic, Zepbound and Wegovy — coupled with limited insurance coverage has fueled a risky but growing “gray” market for purchasing active ingredients from China, Reuters reported recently.

Benzinga · Jul 23, 2025

Kennedy's mental health drug skepticism lands at FDA panel - Roll Call

Democrats have accused Robert Kennedy Jr. of making claims without scientific research to back them and say his claims are dangerous.

Roll Call · Jul 23, 2025

Listeria Contamination Concerns Spark US Tuna Recall: How Serious Is Listeriosis?

Dozens of tuna salad products have been recalled from stores in seven US states due to possible listeria contamination, a bacteria that can lead to deadly infections like listeriosis.

International Business Times UK · Jul 23, 2025