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Months after Johnson & Johnson turned its back on the hypertension treatment Tryvio, Idorsia has secured the FDA’s nod for the endothelin receptor blocker.
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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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GlaxoSmithKline plc and Vir Biotechnology, Inc. announced an update to preclinical data on bioRxiv1, a preprint server, demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the full known Omicron spike protein, the new SARS-CoV-2 variant.
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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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This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.
The checkpoint inhibitor is approved for several cancers in China, but after an indefinite FDA delay last summer, BeiGene’s partner Novartis still awaits its first U.S. approval.
Abdera Therapeutics will use the money to fund its ROVEr platform and advance its lead asset ABD-147 for small-cell lung cancer.
Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone.
As companies prioritize in-person work, many have begun to do more to incentivize a reluctant workforce to come into the office.
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.