US FDA declines to approve Camurus' rare hormone disorder drug
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...
FierceBiotech24m
FDA grants de novo clearance to airway stent covered with human tissue
The FDA has granted a de novo clearance to a new type of stent designed to hold open the passages down the windpipe and into ...
MassDevice1h
Siemens Healthineers wins FDA nod for heart-attack-predicting test
Siemens Healthineers says a new FDA clearance will advance the care of people at risk of heart attacks in the United States.
BioSpace1h
FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems
The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its ...
FiercePharma1h
FDA stymies Camurus' hormonal disorder drug due to 3rd-party manufacturing issues
The FDA issued a complete response letter (CRL) to Camurus, dealing a setback to the Swedish drugmaker’s efforts to bring its ...
Amid backlash, FDA changes course over shortage of weight-loss drugs
The FDA said Eli Lilly’s weight-loss drugs were no longer in shortage on Oct. 2, preventing pharmacies from making cheaper ...
Antidepressant recall: FDA upgrades medication risk class to 2nd highest level in recall update
The U.S. Food and Drug Administration is urging patients not to stop taking their prescribed medication if it falls under the ...
Missouri, Idaho, and Kansas Are Suing The FDA Over Ridiculous Fears About Medication Abortions
The reasoning in their complaint turns pregnant kids into the property of the state.
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Local surgeon gives insight to new FDA guidelines for mammograms
New updates to mammogram guidelines from the FDA can help determine how how often you need one as well as the types of tests ...
Listeria contamination prompts recall of generic waffle brands at retailers across U.S., FDA says
Generic waffle brands at retailers across the U.S. are being recalled after listeria, a potentially fatal bacterial disease, ...
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...