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 ...
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, ...
JD Supra20h
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 ...
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 ...
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 ...
JD Supra2d
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
The Associated Press on MSN7d
Newsom committed California to making its own insulin. It’s at least a year behind his schedule
Gov. Gavin Newsom in 2020 signed a law allowing California to manufacture its own insulin, an effort to bring down the cost ...