Jyong Biotech targets urinary disorders with a novel botanical pipeline, but clinical and liquidity risks temper near-term ...

Vaccines are one of the greatest public health successes of modern medicine. From smallpox to polio to measles, vaccines have ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

Eli Lilly's Alzheimer's drug, donanemab (Kisqali), just got a thumbs-up from the European Medicines Agency's (EMA) expert ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

A high dose of centanafadine was shown to be safe and effective at lowering ADHD symptoms for adolescents, according to ...

Overview of Companion Diagnostics MarketThe Companion Diagnostics Market is evolving rapidly, driven by the growing demand ...

Overview of Artificial Blood Cells MarketThe global Artificial Blood Cells Market is valued at USD 1.355 Billion in 2024 and is projected to reach a value of USD 5.265 Billion by 2035 at a CAGR ...

The CHMP’s recommendation for ZURZUVAE will now be reviewed by the EC for marketing authorization in the European Union with a final decision expected in the third quarter of 2025. The U.S. FDA ...