FDA Related News

Biologics

Gottlieb Believes CBER Will Probe Sarepta Approval

Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sareptas approval of Duchenne muscular dystrophy gene therapy Elevidys based on two...

FDA General

FDA Webview Closed on Juneteenth (6/19)

FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.

Human Drugs

FDA Warns on Transderm Scop Heat Complications

FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-relate...

Marketing

DTC Ads Kennedys Next Target?

Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies away from DTC advertis...

Human Drugs

FDA Approves Gileads Yeztugo for HIV Prevention

FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.

Human Drugs

GDUFA Post-Warning Letter Meeting Guidance

FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...

Open Bipartisan Probe of RFK Vaccine Plans: Pallone

House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary Robert Kennedys act...

Biologics

CBERs Prasad Named Chief Medical/Scientific Officer

CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissioner Marty Makary.

Human Drugs

Commissioners National Priority Voucher Program

FDA launches the Commissioners National Priority Vouchers to speed drug reviews for companies with products that are aligned with national priorities ...

Human Drugs

Aldeyra Files NDA Resubmission for Dry Eye Drug

Aldeyra Therapeutics resubmits an NDA for reproxalap to treat the signs and symptoms of dry eye disease.