Latest Biotech News

The FDA issued draft guidance on how to assess the safety of genome editing in human gene therapy products using next-generation sequencing (NGS). The agency’s recommendations focus on designing...

Revolution Medicines reported that its RAS inhibitor daraxonrasib met key endpoints in a pivotal phase 3 trial in previously treated metastatic pancreatic ductal adenocarcinoma, posting overall...

Cabaletta Bio disclosed that the first two patients have been dosed with its investigational autologous CD19 CAR T therapy rese-cel (resecabtagene autoleucel) after automated manufacture on...

Regeneron and Telix announced a partnership valued at up to $4.3 billion to co-develop and co-commercialize next-generation radiopharmaceutical therapies and companion diagnostics. Under a...

Travere Therapeutics’ sparsentan (Filspari) won FDA approval for focal segmental glomerulosclerosis (FSGS), expanding the label for a drug that had already received accelerated clearance for IgA...

The FDA asked Eli Lilly to provide additional data to assess cardiovascular and liver risks for Foundayo, the company’s newly approved obesity pill. The request reflects the agency’s concern about...

Eli Lilly agreed to acquire CrossBridge Bio for up to $300 million in cash as it expands its antibody-drug conjugate (ADC) oncology pipeline. The Houston-based startup is developing dual-payload...

Harbinger Health raised $100 million in a Series B financing to support commercialization of its Resolve blood-based multi-cancer detection tests. The company said the portfolio is designed to...

Fortrea introduced an AI-powered suite of clinical trial services built around its FIT platform, aimed at improving trial efficiency and reducing operational risk. The company said FIT is designed...

Lightcast raised $27 million to advance Envisia, its massively parallel droplet-based single-cell functional assay platform. The company said the funding will support commercialization of Envisia,...

The FDA cleared Travere Therapeutics’ Filspari (sparsentan) for focal segmental glomerulosclerosis (FSGS), handing the company its long-awaited label expansion after a prolonged regulatory path....

Regeneron and Telix announced a $2.1 billion radiopharmaceutical collaboration that combines Regeneron’s antibody discovery platforms with Telix’s radiopharmaceutical development, manufacturing,...

Eli Lilly agreed to buy CrossBridge Bio for up to $300 million, aiming to strengthen its antibody-drug conjugate (ADC) capabilities with a next-generation, dual-payload approach. CrossBridge,...

The FDA released draft guidance outlining how sponsors should use next-generation sequencing (NGS) to assess off-target risks in genome-edited human gene therapy products. The draft...

Revolution Medicines reported that daraxonrasib met key survival endpoints in a Phase 3 trial in metastatic pancreatic ductal adenocarcinoma, with results that nearly doubled outcomes versus...

Allogene Therapeutics delivered early Phase 2 efficacy data for cema-cel, its off-the-shelf CAR-T program in first-line consolidation large B-cell lymphoma (LBCL). In the company’s reported...

Biognosys and the Michael J. Fox Foundation for Parkinson’s Research (MJFF) announced a collaboration to develop targeted biomarker assays for LRRK2, a major genetic driver of late-onset...

Revolution Medicines led a fresh wave of biotech stock offerings totaling $1.5 billion, according to the latest reports, with Spyre Therapeutics and Allogene Therapeutics also filing. The capital...

Spyre Therapeutics reported early Phase 2 results for SPY001 in ulcerative colitis, saying the program met the study’s primary objective after 12 weeks. The company disclosed a statistically...

The FDA urged clinical trial sponsors to report results after an internal review found that outcomes were missing for about 30% of registered studies. The agency sent reminders to roughly 2,200...