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 ...
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
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 Supra11h
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 ...
Cryoport facilities land FDA approval
It's one of many steps for the company as it builds the infrastructure for what "will change medicine everywhere in the world ...
BioSpace7d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
SiliconRepublic2d
CergenX making Waves with new FDA designation
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
Trump Appointees Must Temporarily Approve Federal Health Communications
W ith respiratory-disease season in full swing and a bird flu outbreak rapidly evolving, the new Trump Administration has ordered federal health agencies to secure White House approval before ...
Teal Health raises $10M to create at-home cervical cancer screenings
The process of getting screened for cervical cancer is quite intimidating. It’s the once-a-year, sometimes life-changing ...
The Dangers Hidden In CMS’ Drug Pricing Regulation
The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to ...