A new FDA application for vepdegestrant offers hope for advanced breast cancer patients with ESR1 mutations, showcasing ...

The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, ...

Kura Oncology and Kyowa Kirin submitted data from the KOMET-001 trial, which the agency will review and decide whether to approve the drug by Nov. 30.

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...

SHELTON, CT / ACCESS Newswire / June 4, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company ...

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene ...

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed ...

A Hong Kong University of Science and Technology (HKUST) research team has developed a catalytic enantioselective type II ...

The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices.

XP 8121 is a combination drug meant to better control hypothyroidism, in part by moving its common therapy, levothyroxine, ...

Tenpoint Therapeutics announced that the new drug application (NDA) for its presbyopia candidate, brimochol PF, has been ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid ...