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FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
Top FDA vaccine official rejected broad use of Covid-19 shots, documents show
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...
FDA Will Now Require Labeling of ADHD Medication to Indicate Weight Loss Risk
Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants ...
US FDA approves Regeneron's blood cancer therapy
Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood ...
Top FDA official rejects COVID-19 vaccines, citing unknown risks
While both the Novavax vaccine and the newest generation of the mRNA Moderna vaccines had been signed off on by about 30 FDA vaccine officials, Prasad ended up writing overrides for each, restricting ...
Regeneron Gets Accelerated FDA OK of Lynozyfic for Blood Cancer Treatment
Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood ...
Blueberries to Die For? Major Recall for Listeria After FDA Announcement
A recall was announced after bacteria were found that could cause serious adverse health consequences or death.
Dr. George Tidmarsh: FDA Declared Substances Like Talc Were Safe In The 1970s, Never Reexamined Them
Dr. George Tidmarsh, physician, scientist, and biotech CEO, joins Jerry Rogers on "The Business of America" podcast to ...
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FDA Mulls ‘Regulatory Action’ on Argenx’s Vyvgart Hytrulo Over Severe Safety Concerns
The safety update for Vyvgart rattled argenx’s shares on Monday, a reaction that analysts at William Blair said was “overdone ...
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FDA Grants Breakthrough Designation for Novel Bladder Cancer Diagnostic
The FDA designates the TOBY Test as a breakthrough device, revolutionizing bladder cancer detection with a non-invasive, ...
Aldeyra Therapeutics: Pivotal FDA Decision After Reproxalap's Chamber Data
Aldeyra's Reproxalap progresses towards FDA approval, with a potential $100M AbbVie deal. There’s still upside potential, ...
Family of Penn Hills officer who died by suicide after Lasik surgery receives letter from FDA
A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason. Now his ...