Moderna Inc. gained US approval for a new Covid vaccine for a narrower group of people, in the latest sign that regulators ...

Every healthcare company claims to be working in the patient's best interest, and yet prices only seem to rise.

The FDA expects that randomized, controlled trial data on clinical outcomes will be needed before COVID-19 vaccines can be approved for patients who are 6 months to 64 years of age and do not have ...

Moderna MRNA announced that it has submitted a regulatory filing with the FDA seeking approval for an updated version of its ...

A federal deadline ending sale of off-brand weight-loss and diabetes medications is now in effect, cutting off access to ...

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

But regulation of drug development begins long before the approval deadline ... gene therapies and products that use CRISPR to the list of products that might be seen as riskier to pursue.

Among other differences from FDA-approved drug products ... drug is when the FDA approved drug appears on the drug shortage list at the time of compounding, distribution, and dispensing.

April 21, 2025 – The FDA just approved the popular drug Dupixent ... an adult should supervise the shots. Dupixent's list of uses already includes asthma, eczema, chronic sinus inflammation ...

Imfinzi also added perioperative treatment of muscle invasive bladder cancer to its list of FDA-approved indications. The newest FDA nod covers use of the drug in combination with chemotherapy ...

Blujepa (gepotidacin) is the first new antibiotic class approved in nearly 30 years, providing a crucial treatment option for drug-resistant ... Diarrhea topped the list, occurring in 14 to ...

The growing list of indications is key to J&J’s plan ... Eli Lilly’s Omvoh became the first IL-23 drug approved in ulcerative colitis in October 2023, while AbbVie’s Skyrizi hit the scene ...