Regulatory
Biogen’s Aduhelm was approved on June 7, 2021, for Alzheimer’s patients, and the controversy continues to grow.
Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.
On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
There are two PDUFA dates on the U.S. Food and Drug Administration’s calendar for this week. Here’s a look.
Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention.
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
After the July 4 holiday, the U.S. FDA has several things on their immediate calendar, including a couple target action dates and an advisory committee hearing. Here’s a look.
Ahead of the July Fourth holiday, the U.S. Food and Drug Administration has two PDUFA dates on the calendar. Here’s a look.
The U.S. Food and Drug Administration (FDA) has made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.
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