US FDA Launches AI Tool to Reduce Time Taken for Scientific Reviews (Reuters) -The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at ...

The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to 64 years at high risk for severe disease, aligning with the agency ...

HHS Secretary Robert F. Kennedy Jr. asked the FDA "to review the latest data on mifepristone ," but experts say concerns about the abortion pill's safety are misguided.

Williams Farms Repack LLC announced on May 2 it was recalling tomatoes under the both the Williams Farm Repack label and the H&C Farms label for potential salmonella contamination.

Iopofosine-131 has been granted breakthrough therapy designation by the FDA for relapsed or refractory Waldenstrom macroglobulinemia, indicating its potential to improve treatment outcomes. The phase ...

The FDA has approved darolutamide without chemotherapy for treatment of metastatic hormone-sensitive prostate cancer.The FDA based its approval off results from the randomized phase 3 ARANOTE ...

The FDA's recent limit on COVID-19 booster vaccines and the CDC's lack of recommendations for young children and pregnant women complicate ACIP's ability to approve off-label vaccine use.

As early as day 1, Tryptyr delivered statistically significant natural tear production. Patients taking Tryptyr (versus vehicle) experienced a ≥10-mm increase in natural tear production at day ...

(RTTNews) - Kura Oncology Inc. (KURA) and Kyowa Kirin Co., Ltd. announced the U.S. Food and Drug Administration has accepted Kuras New Drug Application or NDA seeking full approval for ziftomenib ...

FDA assigns PDUFA target action date of January 31, 2026. WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive” or the "Company”), a pharmaceutical ...

Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel ...

Moderna's mNexspike COVID vaccine approved by FDA for older adults and at-risk groups after Phase 3 trial shows improved efficacy and safety profile.