The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
Takeda Pharmaceutical and Ovid Therapeutics announced that the companies have gathered positive data from their Phase II ELEKTRA study of soticlestat in children with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
The medical cannabis market in the United States, even with all of its restrictions, continues to be a fertile area not only for dispensaries, but pharma companies developing cannabis-derived drugs; and proponents say further growth can be generated by educating physicians about medical cannabis.
Cambridge, Massachusetts-based Praxis Precision Medicines raised about $110 million in a Series C financing, led by Eventide Asset Management,
The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
A Paris-based prosecutor initiated an investigation into Sanofi over the company’s drug Depakine, which is on the market for epilepsy and bipolar disorder.