FDA to Ask Sarepta to Halt Elevidys Shipments
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The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's antipsychotic drug in combination with Viatris' antidepressant Zoloft for treating adults with PTSD.
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even after banning the factory from the U.S. market because of quality problems.
The U.S. Food and Drug Administration has approved Juul's original vaporizer and refill cartridges in tobacco and menthol flavors, a source familiar with the matter told Reuters on Thursday. The FDA in 2022 had banned Juul's four varieties of tobacco and menthol-flavored pods and the e-cigarette device after it concluded that the company failed to show that sale of these products would be appropriate for public health.
The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending the British drugmaker's U.
Since US President Donald Trump – just days into his second term – began imposing tariffs on China for its role in the flow of deadly opioids like fentanyl into the United States, Beijing’s message has been clear.
The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to the brink of bankruptcy.
Real change takes a long time, and when it happens, it must be recognized. The FDA and the NIH have announced their move away from animal testing, improving scientific outcomes and marking a victory over bureaucratic entrenchment.
A son of notorious Mexican drug kingpin “El Chapo” pleaded guilty Friday to US drug trafficking charges. He is the first of El Chapo’s sons to enter a plea deal.
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U.S. drug enforcement agents seized more than $10 million in cryptocurrency linked to Mexico's Sinaloa cartel during raids that also netted massive quantities of fentanyl and other drugs, officials say.
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's drug when used in combination with Viatris' Zoloft for the treatment of adults with PTSD.
The U.S. Food and Drug Administration has authorized the sale of Juul's e-cigarette device and refill cartridges in tobacco and menthol flavors, a source familiar with the matter told Reuters on Thursday.
The FDA and A.P. Deauville issued a voluntary recall of over 67,000 cases of Power Stick deodorant last week that were sold across the country.