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

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

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

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, 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.

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 ...

Pfizer is cutting costs, growing its core business, and trading at a deep discount despite looming patent losses and COVID ...

Arquitos Capital Management gained 13.1% in Q2 2025. Learn how they turned market uncertainty into opportunity with Liquidia ...

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 ...

Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...