As the world prepares for a potential coronavirus pandemic, the U.S. government has been busy making preparations for the possibility of a flu pandemic. The U.S. Food and Drug Administration approved Seqirus’ Audenz, a vaccine for a potential pandemic associated with the H5N1 flu virus.
The U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy Palforzia as a first-of-its-kind treatment for the millions of people suffering from an allergy to peanuts.
In a second research report published this year so far, investigators found that the U.S. Food and Drug Administration (FDA) is approving drugs faster than ever.
The Food and Drug Administration approved an autoinjector device for Teva Pharmaceuticals USA Inc.’s Ajovy (fremanezumab-vfrm) injection.
The U.S. Food and Drug Administration approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly’s Trijardy XR for lowering blood sugar in adults with type 2 diabetes.
The U.S. Food and Drug Administration approved Merck’s Dificid (fidaxomicin) for a new oral suspension as well as for the treatment of Clostridioides difficile-associated diarrhea (CDAD) in children ages 6 months and older.
Epizyme’s oral potent, first-in-class EZH2 inhibitor tazemetostat won accelerated approval from the U.S. Food and Drug Administration for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Ireland’s Horizon Therapeutics became the first to win regulatory approval in the United States for the treatment of Thyroid Eye Disease (TED), a progressive autoimmune disorder that can threaten the vision of those afflicted.
Novo Nordisk’s Ozempic (semaglutide) won approval from the U.S. Food and Drug Administration to reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
The U.S. Food and Drug Administration approved Neurelis Inc.’s Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older.
