Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study ...

Ophthalmic diseases specialist Oculis Holding AG announced positive phase II data showing its serum-glucose corticoid ...

Ophthalmic diseases specialist Oculis Holding AG announced positive phase II data showing its serum-glucose corticoid kinase-2 activator OCS-05 protected nerve cells and improved vision in patients ...

HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the ...

Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both ...

Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s ...

Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The ...

South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% ...

With artificial intelligence (AI) becoming more and more common in drug development since 2016, the U.S. FDA is now issuing its first draft guidance on that use. The “FDA recognizes the increased use ...

Publication on Dec. 12, 2024, of data analysis regarding Merck & Co. Inc.’s Winrevair (sotatercept) in Clinical Pharmacology & Therapeutics may have put investors in mind of the odds for the activin ...

Toll-like receptors (TLRs) are crucial to trigger anticancer immune responses. Despite the promise of TLR agonists as potential anticancer agents, few have reached the clinics due to concerns related ...

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