Latest Biotech News

The FDA has approved Eli Lilly’s oral GLP-1 obesity drug orforglipron for adults with obesity or overweight plus weight-related conditions, marketed as Foundayo. Approval follows Lilly’s expected...

Biogen agreed to acquire Apellis Pharmaceuticals for about $5.6 billion, extending the company’s immunology and rare-disease footprint. The deal brings two marketed therapies—Empaveli and...

Eli Lilly agreed to buy Centessa Pharmaceuticals for $6.3 billion upfront, plus additional potential value via contingent payments, securing Centessa’s orexin receptor 2 (OX2R) agonist pipeline...

FDA Commissioner Marty Makary said the agency is seeking to speed new US clinical trial processes by reducing the amount of data needed to start a trial, focusing on the portions tied to safety....

Researchers working on custom CRISPR therapies said FDA expectations for individualized genetic medicines could make scaling difficult, citing stringent manufacturing and quality control...

Caris Life Sciences reported finalized Achieve I results for its multi-cancer early detection blood test Caris Detect, updating performance metrics for sensitivity and specificity across cancer...

Geneus Technologies obtained CE marking under the EU In Vitro Diagnostic Regulation (IVDR) for its single-molecule nanopore sequencer G-seq500 and companion sequencing chip G-MK02. The...

AAV manufacturing teams are under pressure to scale while keeping vector quality consistent, particularly during the narrow transfection-complex preparation window. A reported approach describes a...

Perceptive eClinical and Kayentis announced a partnership designed to streamline clinical trial operations by integrating interactive response technology (IRT) with electronic clinical outcome...

Merck entered a discovery collaboration with Infinimmune to develop multiple therapeutic antibodies across immune-related targets. The agreement provides for up to $838 million in upfront and...

Eli Lilly’s orforglipron, marketed as Foundayo, cleared the FDA on Wednesday under the agency’s commissioner’s voucher program, positioning the once-injectable GLP-1 class for a fresh competitive...

Eli Lilly agreed to acquire Centessa Pharmaceuticals in a $6.3 billion transaction, betting its orexin receptor 2 (OX2R) agonist pipeline can expand neuroscience growth beyond Lilly’s obesity cash...

IO Biotech moved to bankruptcy after the company failed to secure an FDA path for its cancer vaccine following a pivotal phase 3 outcome. In an SEC filing, the Danish developer said it intends to...

Ambrosia Biosciences landed $100 million in oversubscribed Series B financing to advance an oral small-molecule GLP-1 program it says is designed to compete with Novo Nordisk’s Wegovy. The company...

Caris Life Sciences shared finalized Achieve I results for its multi-cancer early detection test Caris Detect, driving a sharp stock reaction. The study enrolled 3,014 evaluable patients and...

Memorial Sloan Kettering researchers described a new CAR T strategy aimed at uPAR-positive tumor ecosystems, seeking to expand solid-tumor targeting beyond single tumor-cell antigens. In...

The FDA delayed its decision on Orca Bio’s T cell therapy after the company filed additional manufacturing data, extending the agency’s review timeline by three months. The new decision deadline...

Geneus Technologies announced that its G-seq500 single-molecule nanopore sequencer and sequencing chip, G-MK02, obtained CE marking under the EU’s IVDR framework. The certification is framed by...

Korsana Biosciences is set to go public through a reverse merger with Paragon Therapeutics’ offshoot Korsana, aiming to bring an Alzheimer’s antibody asset into the next stage with additional...

A new collaboration seeks to develop a place-of-care manufacturing platform for autologous gene-modified hematopoietic stem cells, combining automation technology with academic and access-focused...