Food and Drug Administration (FDA)
NEWS
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. Biogen, on its part, has defended its pricing.
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 company indicated it was pausing distribution out of an abundance of caution and would continue investigations.
Multiple pharma company stocks make their first appearance on the Nasdaq this morning to advance the next-generation therapeutics. BioSpace takes a look at some of these IPOs.
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.
Roche had a big week, scoring wins but also stepping away from its gene therapy partnership with 4D Molecular Therapeutics.
The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.
The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
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