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FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval ...
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 ...
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 ...
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 ...
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FDA approves Dizal’s Zegfrovy to treat adults with NSCLC
Dizal has received FDA approval for Zegfrovy to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
US FDA Approves Regeneron's Blood Cancer Therapy
(Reuters) -The U.S. Food and Drug Administration has approved Regeneron's cancer therapy, the company said on Wednesday, ...
BioSpace20h
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 ...
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 ...
Chocolate Mousse Recall as FDA Issues Highest Risk Warning
Sabores Fit Bakery recalled a variety of its mousse desserts on June 20 because of the undeclared presence of allergens.
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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, ...
Fierce Biotech14h
53 biotech leaders urge FDA not to restrict mifepristone access over 'fatally flawed' report
A group of 53 biotech leaders are expressing their support for mifepristone in a letter to the Food and Drug Administration, ...