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FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...
McKnight's Senior Living2d
FDA approves Gemtesa for overactive bladder in men with BPH
Gemtesa is approved for men with overactive bladder symptoms who are receiving pharmacologic treatment for benign prostatic hyperplasia.
Biotech Stocks Facing FDA Decision In January 2025
As we enter the new year, all eyes are on the biotech companies awaiting key FDA decisions in January. In 2024, the FDA approved 50 ...
Business Wire6d
Inogen Receives FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device
“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy ... Forward-Looking Statements This press release contains forward-looking statements within the meaning of the ...
McKnight's Long-Term Care News9d
FDA approves Zepbound for sleep apnea in patients with obesity
The US Food and Drug Administration has approved Zepbound (tirzepatide) as the first prescription medication for the treatment of obstructive sleep apnea (OSA).
FDA proposes new testing rules to ensure cosmetics are asbestos-free
The Food and Drug Administration is proposing a rule that cosmetic companies would have to take extra steps to ensure that ...
news10nbc10d
Systane eye drops recalled for possible fungal contamination, FDA says
Systane brand eye drops were voluntarily recalled because of possible fungal contamination, the Food and Drug Administration ...
Fox 1310d
Potential 'fungal contamination' leads to nationwide recall of popular brand of eye drops: FDA
A popular brand of eye drops is being recalled nationwide after a consumer reported a "foreign material" was found in a ...
Off-brand versions of Lilly weight loss drug must be pulled off market, could mean higher prices
The United States Food and Drug Administration says the shortage of Eli Lilly’s Zepbound and Mounjaro drugs has been resolved ...
FDA approves first medication for obstructive sleep apnea, which also promotes weight loss
The FDA approved a new drug treatment for obstructive sleep apnea that improves the condition through weight loss. Sleep ...
FDA approves generic in same class as Ozempic for diabetes. Could it ease shortage, price?
The drugs were first approved to treat type 2 diabetes – and that's what the FDA said daily injections of liraglutide could ...
Cure Today13d
FDA Grants Breakthrough Therapy Designation to Trodelvy for Small Cell Lung Cancer
The FDA has granted breakthrough therapy designation Trodelvy for adults with extensive-stage small cell lung cancer who ...