Latest Biotech News

Avalyn Pharma launched a $300 million initial public offering, planning to trade on Nasdaq to fund late-stage work on reformulated inhaled respiratory drugs. The IPO is positioned to support...

CareDx agreed to acquire Naveris in a deal worth up to $260 million, giving it access to NavDx, a liquid biopsy test for HPV-related cancers. The acquisition adds tumor-naïve minimal residual...

The FDA announced a pilot effort to review clinical trial data in real time, aiming to reduce reporting lag and improve reviewer access as data accrues. The agency said the program will build on...

French researchers published population-based 3-year outcomes data for children who experienced hypoxic-ischemic encephalopathy (HIE) as neonates, adding long-horizon evidence on incidence and...

Researchers at the Icahn School of Medicine at Mount Sinai reported that detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma models. Published...

PTC Therapeutics released top-line results from the 24-month interim analysis of Pivot-HD, reporting dose-dependent “favorable” effects on disease progression for stage 2 Huntington’s disease...

The FDA placed a clinical hold on enrollment in Newron Pharmaceuticals’ U.S. Phase 3 schizophrenia trial ENIGMA-TRS 2 after a patient death occurred outside the country. Newron said the sudden...

South Korea’s MFDS approved Curocell’s anbalcabtagene-autoleucel (Limcato) as the first homegrown CAR T-cell therapy for patients with advanced diffuse large B-cell lymphoma. The approval marks a...

Guardant Health and Nuvalent have struck a multi-year collaboration to build and commercialize oncology companion diagnostics. The deal will leverage Guardant’s tissue and liquid biopsy portfolio...

Novartis disclosed plans to build another factory in the US as part of its $23 billion expansion commitment, marking the final new build in the program. The company said it has allocated every...

The FDA announced a pilot effort to collect and review clinical trial data in real time, aiming to reduce delays between trial events and regulatory assessment. The initiative will build on...

Chiesi agreed to acquire KalVista Pharmaceuticals for about $1.9 billion, adding a commercialized hereditary angioedema (HAE) treatment to its rare-disease franchise. Under the deal structure...

GSK and Alector terminated a phase 2 Alzheimer’s disease program after an interim analysis indicated the trial would be unlikely to reach its primary endpoint. The decision followed the companies’...

Leo Pharma is paying $50 million for Replay, a US gene-writing biotech, and its preclinical gene therapy program for a rare skin disease. The purchase is focused on Replay’s high-payload...

South Korea’s MFDS cleared Curocell’s Limcato (anbalcabtagene-autoleucel) as the first locally developed CAR T-cell therapy for advanced diffuse large B-cell lymphoma. The approval positions...

Boehringer Ingelheim reported that its dual-acting obesity drug survodutide succeeded in a phase 3 trial, producing significantly greater weight loss than placebo in a 76-week study. The company...

CareDx agreed to acquire Naveris for up to $260 million, expanding its precision oncology diagnostics footprint. The transaction gives CareDx access to NavDx, a liquid biopsy test for HPV-driven...

Moleculent raised $20 million in an extended Series A to commercialize its spatial functional proteomics platform for profiling cell-cell communication. The round was led by Rubicon Healthcare...

The U.S. FDA moved toward faster decision-making by launching a pilot program to collect and review clinical trial data in real time. The agency said it will give reviewers access to information...

GSK and Alector terminated a Phase 2 Alzheimer’s trial after an interim analysis indicated the study was unlikely to meet its primary endpoint. The stop reflects continued difficulty translating...