The U.S. Food and Drug Administration's staff on Wednesday raised concerns over the efficacy of Intercept Pharmaceuticals' ...

FDA staff reports suggest the agency might want to rethink those approvals in light of new evidence the drugs' efficacy is limited to certain subgroups that can be defined by PD-L1 expression.

Certain lots of Answers dog food and Darwin's Natural Pet Products, which includes dog and cat food, have been recalled after ...

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for ...

The recall involves updating instructions for use, rather than removing devices from where they are used and sold ...

Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced ...

FAISALABAD, Sep 23 (APP):Faisalabad Development Authority (FDA) Director General Muhammad Asif Chaudhry on Monday said that ...

Neuralink, the medical technology company founded by Elon Musk, received an important clearance from the Food and Drug Administration that may allow the brain implant system to help people with ...

Last year, the FDA approved Eli Lilly’s CDK4/6 inhibitor, abemaciclib or Verzenio, for use in stage 2 and 3 HR positive, HER2 negative breast cancer, but not for breast cancers that had not yet ...

Last week, readers were most interested in a story about how diagnostic firms may be impacted by the FDA's final rule on laboratory-developed tests.

New rules proposed by the California Board of Pharmacy threaten to limit access to glutathione, which has shown great promise ...

Attorneys for sexual abuse victims of a convicted Fort Mill church youth leader are suing him and his former church, ...