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 ...
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 ...
FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
FierceBiotech20m
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 ...
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 ...
Novavax Stock Plunges After FDA Pauses Covid, Flu Vaccine Trials
Novavax shares tumbled after the Food and Drug Administration put a clinical hold on its testing applications for a combined ...
Cookies Recall Update as FDA Sets Highest Risk Level
More than 10,000 packages of cookies have been recalled after they were found to contain an undeclared allergen. In September ...
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and ...
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 ...
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 ...
FierceBiotech1d
Lykos accepts FDA’s view that reviving rejected MDMA therapy’s fortunes requires fresh phase 3 trial
Lykos Therapeutics may have shed three-quarters of its staff in the wake of the FDA's rejection of its MDMA candidate for ...
SeafoodSource5h
FDA issues warning letters to Spanish, Venezuelan seafood importers for safety risks
The U.S. Food and Drug Administration (FDA) has issued warning letters to Spain’s Bacalao Giraldo and Venezuela’s Procesadora ...