FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
BioPharma Dive7d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Becker's Hospital Review7d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
JD Supra8h
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
Scilex FDA submission for ELYXYB acute pain treatment acknowledged
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...
Newsom committed California to making its own insulin. It’s at least a year behind his schedule
Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is ...
Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update
GRAFAPEX™ (treosulfan) for injection is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that ...
JD Supra7d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...