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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Jnana Therapeutics forged its second small molecule discovery and development collaboration and licensing agreement with Roche valued at up to $2 billion.
ImmunoGen’s Elahere was approved Monday under the FDA’s accelerated pathway for patients who have received one to three previous lines of systemic therapy.
The FDA raised doubts about the future of Ardelyx’s experimental chronic kidney disease drug tenapanor in briefing documents released ahead of a Wednesday advisory committee meeting.
Stoke Therapeutics is gearing up for a pivotal trial of its lead program for a rare genetic epilepsy disease and announced positive results from its Phase I/IIa study in children with Dravet syndrome.
Indivior PLC announced it will acquire Opiant Pharmaceuticals and its lead candidate OPNT003, an intranasal-delivered opioid overdose recovery product.
During its third-quarter earnings call Monday, BrainStorm Cell Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in ALS.
Topline results from the Phase III SUMMIT trial showed Satsuma Pharmaceuticals’ migraine candidate STS101 did not meet its primary efficacy endpoint.
Ionis Pharmaceuticals inked a collaboration deal with Metagenomi with the goal of adding DNA editing to its RNA-targeted technologies focused on up to four genetic targets.
MBX Biosciences secured $115 million in Series B financing to advance its pipeline of Precision Endocrine Peptides for endocrine disorders.
Find out everything you need to know about research and development, including the skills it requires and what you should do if you’re ready to make the transition into R&D.