F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia
Federal regulators will no longer require patients to provide blood tests before receiving the drug from pharmacies.
Drug compounders sue over weight loss drugs’ removal from FDA shortage list
A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for ...
Map Shows States With Listeria Cases as FDA Recalls Nutritional Shake
A nationwide recall of frozen nutritional shakes has been issued after a listeria outbreak tied to the drinks resulted in ...
Smokescreen: some vape firms pivot after FDA crackdown
Such tactics have complicated U.S. efforts to stem the flow of vapes lacking authorisation into the country, according to the ...
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
The Food and Drug Administration is scrambling to bring back hundreds of critical workers laid off en masse by DOGE.
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Drug compounders sue FDA over Novo Nordisk’s Ozempic, Wegovy
Drug compounders aren’t ready to give up their ability to produce off-brand versions of Novo Nordisk’s weight-loss drug ...
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FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
Roughly a year after receiving an FDA reprimand at its manufacturing plant in Michigan, Indian drugmaker Piramal Pharma has ...
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Emalex Heads to FDA After Phase III Tourette Syndrome Win
In the Phase III trial, 41.9% of pediatric Tourette syndrome patients relapsed after ecopipam treatment, as compared with ...
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The FDA's new standards for foods before they can be labeled as "healthy" on their packaging will go into effect about two ...
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Nasal spray recalled nationwide; risk of infection: FDA
The U.S. Food & Drug Administration (FDA) has announced the voluntary recall of a sinus nasal wash bottle system following a ...
Opus Genetics gets FDA Fast Track designation for Phentolamine Ophthalmic Solution
Opus Genetics (IRD) said that the FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75%, reported ...
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Trump’s FDA navigates layoffs, exits, and a new hire
The Trump administration has started rehiring some of the FDA employees it fired last week, the latest chapter in a haphazard ...