AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.

The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...

In four months, the program, which aims to modernize how the FDA reviews imported products, increased processing speed by 66% ...

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...

Treatments for are allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia under review.

The Phase 1 clinical study of FAP-Exd (AVA6103) is anticipated to begin later in Q1 2026LONDON and PHILADELPHIA, (GLOBE NEWSWIRE) ...

Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date ...

Schrödinger, Inc. (Nasdaq: SDGR) provided an update on its progress across the business in 2025 and announced its strategic ...

The newly launched program builds on previously published, peer-reviewed clinical research ( link to full publication) demonstrating that surface acoustic wave micro-vibration technology applied to ...

Novo Nordisk A/S (NYSE: NVO) on Thursday submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema. The application covers CagriSema for use with ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — A new program ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, today announced that the ...