ADAR1 Capital Management, LLC (together with its affiliates, "ADAR1" or "We"), the largest stockholder of Keros Therapeutics ("Keros" or the "Company") with approximately 13.3% of the Company's ...

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company ...

Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry ...

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson's disease which is currently in early-stage clinical testing.

Bayer's big investment in time and ... a CKD indication for their class-leading SGLT2 drug Jardiance (empagliflozin), under a fast-track review by the FDA. Johnson & Johnson's Invokana ...

The FDA has appointed its first chief artificial intelligence officer, with an eye on supporting the agency’s internal IT systems and potentially accelerating its reviews of medical products.

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses.

The FDA review of NVO's oral Wegovy comes at a time when rival Eli Lilly (LLY) is preparing to launch its oral weight loss therapy, orforglipron, next year. In April, the Indiana-based drugmaker ...

The U.S. Supreme Court is expected to decide by late 2025 or early 2026 whether to review a glyphosate case. If the court rules in Bayer’s favor, the company could reverse a €6 billion ...

April 29 (Reuters) - The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the agency under the Trump administration, its chief said.

The FDA has completed its 30-day review of an application for Hepzato in combination with standard of care in liver-dominant metastatic breast cancer. Among patients with liver-dominant metastatic ...

The AI tools will be deployed immediately and will expedite the review process by enabling FDA scientists and subject-matter experts to spend less time on “tedious” and “repetitive” tasks. FDA ...