The new approval goal date is August 9, 2025 ... time to review our recent submission and additional information request for the ketamine new drug application," said Fabio Chianelli, CEO of ...

The new approval goal date is August 9, 2025 ... time to review our recent submission and additional information request for the ketamine new drug application," said Fabio Chianelli, CEO of ...

“While we were prepared for a decision by June 4, 2025, we acknowledge the FDA’s need for additional time to review our recent submission and additional information request for the ketamine ... made ...

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The new approval goal date is August 9, 2025, revised from the previous date ... need for additional time to review our recent submission and additional information request for the ketamine new drug ...

The FDA is still re­view­ing a la­bel ex­pan­sion for GSK’s res­pi­ra­to­ry drug Nu­cala in chron­ic ob­struc­tive pul­monary dis­ease de­spite the May 7 ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA ...