Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
Jan 15 (Reuters) – The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for…
Flu Patients Struggle to Find Tamiflu as Virus Surges Across US
The antiviral treatment Tamiflu is in short supply in parts of the US, as patients and pharmacists battle…
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI®
BioXcel Therapeutics Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation…
US FDA declines to approve Corcept’s drug for rare hormonal disorder
By Sneha S K and Sahil Pandey Dec 31 (Reuters) – The U.S. Food and Drug Administration has…
Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism
REDWOOD CITY, Calif., December 31, 2025–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery…
Vanda Jumps 21% After FDA Approves Motion Sickness Therapy
This article first appeared on GuruFocus. Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S.…
Inside the FDA’s vaccine uproar
Six days after a senior FDA official sent a sweeping internal email claiming that COVID vaccines had caused…
FDA OKs libido-boosting pill for older women who have gone through menopause
WASHINGTON (AP) — U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido,…
Atorvastatin recall may affect hundreds of thousands of patients – and reflects FDA’s troubles inspecting medicines manufactured overseas
If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late…
Appointment of controversial FDA official rocking agency like “an atom bomb,” scientists there say
The Trump administration’s elevation of a vaccine skeptic to lead a high-profile office within the Food and Drug…