FDA
The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.
On May 29, the FDA cleared T2 Biosystems’ T2Bacteria Panel for diagnosis of sepsis. In that sepsis is the third-leading cause of death in the U.S., this emphasizes the importance of work in this area.
Has the U.S. Food and Drug Administration failed to do its due diligence in finding and reporting financial conflicts of interest between members of its scientific advisory committees and pharmaceutical companies?
Merz Neurosciences announced that the U.S. Food and Drug Administration approved a treatment for chronic drooling in adults.
Shares of Alkermes plc are climbing in premarket trading after the company announced the U.S. Food and Drug Administration approved Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.
Shares of Menlo Park, Calif.-based Dermira jumped more than 10 percent this morning after the U.S. Food and Drug Administration (FDA) approved its therapy for people who have excessive underarm sweating.
After failing to gain market share under the umbrella of Valeant Pharmaceuticals, Addyi is getting a relaunch at half the price.
Array BioPharma, Inc. secured approval for its combination treatment for BRAF-mutant metastatic melanoma.
Pain Therapeutics stock plunged 70 percent after a U.S. Food and Drug Administration (FDA) advisory committee voted 14 to 3 against approval of its Remoxy ER for severe pain.
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