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Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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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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Karuna Therapeutics appointed Bill Meury as its new president and chief executive officer, succeeding its current head, Steve Paul.
Editas Medicine released positive proof of concept data Tuesday morning from the first patients dosed with its experimental CRISPR-based gene therapy for sickle cell disease.
Entact Bio launched with $81 million Tuesday to advance its protein enhancement platform.
Topline results from the Phase II TORREY study showed Gossamer Bio’s seralutinib met its primary efficacy endpoint in pulmonary arterial hypertension.
Mirati’s adagrasib demonstrated a solid safety profile in new data released Monday. Despite this, the company’s stock fell 8% in after-hours trading.
MEI Pharma, Inc. will have a strategic realignment that would see at least 30% of its workforce laid off and a pivot towards two of its earlier clinical-stage assets.
Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.
BioSpace is proud to present its NextGen Bio “Class of 2023,” a list of the hottest recently launched life sciences companies in North America.
SonoThera closed its Series A round of financing Monday, counting $60.75 million in earnings and will use these proceeds to advance its ultrasound-guided, non-viral gene therapy platform.
Novartis announced the Phase III PSMAfore trial of Pluvicto for PSMA-positive metastatic castration-resistant prostate cancer met its primary endpoint.