Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis ...
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging ...
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink ...
Corxel will use the fundraising proceeds to advance the oral GLP-1 therapy CX11 through mid-stage development in the U.S., as ...
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates ...
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid ...
I don’t like established science,” ACIP chairperson Kirk Milhoan said in an interview on the Why Should I Trust You? podcast.
The star of the acquisition, anti-IgE antibody ozureprubart, is being tested as a prophylactic treatment for food allergies, ...
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting ...
Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment ...
After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will ...
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
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