Regulatory
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.
Concerns over vaccination links to heart inflammation are valid, a U.S. Centers for Disease Control and Prevention advisory committee announced this afternoon.
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.
The medical regulator’s green light is a milestone in the global fight against specific types of late-stage blood cancer, as CAR T-cell therapy has been found to be effective against them.
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