Makary’s departure followed internal disputes over approval decisions and Covid-19 vaccine posture, catalyzing a rapid ...
Regeneron and Parabilis Medicines partner to discover and develop antibody-Helicon conjugates, aiming to create a new class of therapies capable of targeting historically “undruggable” intracellular ...
Dr. Richard Graham explains how FDA’s new program allows for the usage of real-time data during clinical trials. In April, ...
Biotech’s ~10-year path from private risk to approved therapy is mismatched with trading-driven capital markets, where minor ...
David Crean, chief business officer at MedicNova, discusses changes at FDA causing variability and unpredictability in ...
In today's Pharmaceutical Executive Daily, FDA approves AstraZeneca's Fasenra as a new treatment for hypereosinophilic ...
ATTAIN-Maintain found oral orforglipron preserved prior loss after injection-to-oral transition, with only 0.9 kg regain from ...
According to him, the industry must address its relationship with the capital markets, address misinformation issues, and push back against the politicization of medical research and development.
Hypereosinophilic syndrome is defined by persistent eosinophilia with eosinophil-mediated organ/tissue damage, driving ...
A full clinical hold suspends dosing and enrollment in the Phase III HERO study and open-label extension, superseding the earlier voluntary pause and freezing near-term registrational timelines.
White House sources indicate Trump approved Makary’s removal, reflecting escalating senior leadership churn across federal health agencies. Makary’s tenure featured MAHA-aligned regulatory positions, ...
Accelerated approval of sonrotoclax establishes a targeted BCL2 option in post–BTK inhibitor relapsed/refractory mantle cell lymphoma, a setting with limited effective salvage therapies and poor ...
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