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In advance of a March 21 PDUFA date, Italfarmaco on Tuesday reported that its drug candidate givinostat met the primary endpoint for treating Duchenne muscular dystrophy.
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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today an additional $150 million commitment through Merck for Mothers to further advance the initiative’s mission of helping create a world where no woman has to die giving life.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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When a person notifies their employer that they have a disability, the company must make a good-faith effort to adjust to enable the employee to continue in their job.
The leaked data show that Carvykti cuts the risk of disease relapse by 74% versus standard chemotherapy regimens.
Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.
Qulipta’s label expansion makes it the first oral CGRP receptor antagonist approved for episodic and chronic migraine.
The checkpoint inhibitor improved patient outcomes in three cancer trials, according to results presented at the AACR meeting.
The acquisition of Bellus Health will give GSK access to camlipixant, a potentially best-in-class P2X3 antagonist for chronic cough.
Omisirge is approved for patients who receive cord blood transplantation following myeloablative therapy.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Roche, AstraZeneca, Moderna, Merck and Affimed presented new data in liver cancer, lung cancer, melanoma and lymphoma.
Thursday, the FDA greenlit Ostuka and Lundbeck’s Rexulti as the first treatment in the U.S. for agitation associated with dementia due to Alzheimer’s disease.