Latest Biotech News

Replimune’s oncolytic immunotherapy RP1 cleared an FDA acceptance hurdle for a third regulatory attempt in advanced melanoma, with a decision expected on or before Aug. 2. The FDA has also...

Researchers at the University of Pennsylvania unveiled an AI-assisted pipeline to nominate and validate CAR-T targets for solid tumors, spotlighting GPNMB as a multi-cancer candidate. The work,...

ARPA-H committed $90.7 million over four years through its Making Obstetrics Care Smart (MOCS) program to speed point-of-care diagnostics and monitoring approaches designed to improve childbirth...

Merck KGaA agreed to acquire Bio-Techne in an $11.3 billion deal, positioning the company to expand its life sciences tools, analytics, and workflows across discovery and advanced therapeutics....

BioMérieux submitted a rapid multiplex syndromic vaginitis panel to the FDA for dual 510(k) clearance and CLIA waiver, aiming to bring point-of-care molecular results to women’s health settings....

At BIO 2026, U.S. biotech executives highlighted mounting tension around U.S.-China licensing deals, where lawmakers are weighing new restrictions amid national security and competition concerns....

RQ Bio raised an oversubscribed $115 million Series A to advance its long-acting antibody prophylaxis program for seasonal influenza. The financing is intended to move RQB-01 toward IND-enabling...

Myriad Genetics expanded access to its Precise MRD ctDNA assay across breast, colorectal, and renal cancers, extending use from treatment through surveillance. The ultrasensitive whole-genome...

An international team led by Icahn School of Medicine at Mount Sinai reported a fully human monoclonal antibody cocktail that provides complete protection against Nipah and Hendra virus infection...

ARPA-H has committed $90.7 million over four years under its Making Obstetrics Care Smart (MOCS) program to accelerate diagnostic tests and fetal monitoring tools aimed at improving childbirth...

The European Medicines Agency has recommended revoking the marketing authorization for Amgen’s rare-disease drug Tavneos, citing “incorrect and misleading” clinical data. The action escalates a...

Biotech stakeholders are bracing for major operational changes as the EU Biotech Act is expected to reduce clinical trial timelines, boost biomanufacturing capacity, and improve investment...

A new wave of scrutiny is building around the US 340B drug discount program, with Sen. Bill Cassidy preparing legislative action and advocates calling for patient-focused reforms and greater...

FDA leadership says the agency is hiring to rebuild capacity after more than a year of workforce attrition tied to DOGE-era cuts and leadership turnover. Acting chief of staff and deputy...

Ionis Pharmaceuticals has received FDA approval to expand Tryngolza (olezarsen) to a broader hypertriglyceridemia label, increasing the therapy’s commercial scope beyond an earlier rare...

Circio and Tcelltech have agreed to collaborate on engineering next-generation in vivo CAR-T and TCR-T therapies using a non-integrating, non-viral vector strategy. The partners will combine...

Researchers at the University of Pennsylvania and Abramson Cancer Center unveiled an AI-driven, human-in-the-loop framework to nominate CAR T cell antigens across solid-tumor contexts. In a study...

Merck KGaA agreed to acquire Bio-Techne for approximately $11.3 billion, expanding the German company’s life science tools footprint across multiomics, spatial biology, cell and gene therapy, and...

Boundless Bio agreed to merge with Serapha Bio in an all-stock deal valued at $230 million, with the combined company expected to trade on Nasdaq under Serapha Bio’s name. The merger is designed...

Merck KGaA agreed to acquire Bio-Techne for about $11.3 billion, a deal positioned to deepen the German company’s presence across the life-science value chain. The transaction adds Bio-Techne’s...