The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...

The FDA has undergone a series of major policy shifts under Marty Makary, MD, MPH, who recently resigned from his position as ...

・The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. ・The company submitted responses and the agency determined that the ...

The FDA has approved zenocutuzumab-zbco as the first drug for certain patients with a rare and aggressive bile duct cancer. Zenocutuzumab-zbco (Bizengri, Partner Therapeutics) received approval for ...

In June, the federal Food and Drug Administration quietly announced a new program, the Commissioner’s National Priority Voucher, which promises the fastest approval in FDA history – just one to two ...