FDA
Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately.
FEATURED STORIES
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
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The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.
The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
It’s not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
In April 2021, the U.S. Food and Drug Administration issued Acadia a Complete Response Letter (CRL) related to its previous attempt to expand the approved indication for Nuplazid.
The FDA will evaluate AMX0035, an investigational oral fixed-dose drug intended for people diagnosed with ALS.
The FDA committee voted 8 yes and 14 no. The decision now goes back to the OND to decide the FDDR on Avenue Therapeutics’ IV Tramadol.
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
After announcing that the FDA was investigating a possible death associated with its lymphoma drug Ukoniq (umbralisib), things are seemingly looking up for TG Therapeutics.
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.