News
Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Merck initiated a tender offer Monday to buy all outstanding shares of Imago Biosciences. This follows the November announcement of the buyout.
Affimed will not seek accelerated approval for AFM13 as a monotherapy in advanced-stage relapsed/refractory peripheral T cell lymphoma.
Amgen confirmed Monday it will acquire rare disease giant Horizon Therapeutics for $26.4 billion.
Wall Street is no longer enamored with NASH drug developers.
Combinations including Ibrutinib stood out in hard-to-treat hematological cancers at the 64th American Society of Hematology (ASH) annual meeting.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
UCB shared positive top-line results Friday from two Phase III studies of bimekizumab for adults with moderate to severe hidradenitis suppurativa.
Autolus Therapeutics is calling the Phase II FELIX trial, assessing its next-generation CAR-T therapy obe-cel for leukemia, a win after an interim analysis revealed an overall remission rate of 70%.
A combination of Exelixis’ cabozantinib and Roche’s Tecentriq missed the primary endpoint of overall survival in a Phase III study.
ImmunoGen entered into a clinical collaboration deal with Gilead Sciences Friday to evaluate the safety and efficacy of two drugs that, when used in concert, have the potential to treat AML.