Latest Biotech News

The FDA granted Fast Track status to elunetirom (ABX-002) as an adjunctive treatment for depressive episodes associated with bipolar I or bipolar II disorder in adults, according to a May 26...

A busy June at the FDA includes 11 upcoming PDUFA dates, with at least eight new products and three label expansions awaiting decisions, according to a regulatory calendar overview. One of the...

Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program, the company said during an event tied to ASCO. Daraxonrasib remains...

Pfizer announced a multi-drug R&D collaboration with Innovent Biologics valued at $10.5 billion, targeting next-generation antibody-drug conjugates (ADCs) for targeted cancer therapies. The deal...

New data from the lidERA Phase 3 trial showed that adjuvant giredestrant, an investigational oral selective estrogen receptor degrader (SERD), cut recurrence risk across both premenopausal and...

B7-H4-directed antibody-drug conjugate puxitatug samrotecan (AZD8205) delivered a 47.1% confirmed objective response rate in B7-H4-expressing recurrent or progressive endometrial cancer in the...

Allogene Therapeutics announced that Zachary Roberts, currently executive vice president of R&D and chief medical officer, will succeed David Chang as president and CEO on July 1, and will also...

Signos raised $20 million to expand its glucose monitoring platform beyond diabetes by targeting weight loss, the company said. The approach combines an over-the-counter Dexcom CGM with an app...

Revolution Medicines delivered what oncologists described as “landscape-changing” data for daraxonrasib at ASCO, extending survival in second-line metastatic pancreatic cancer with...

Akeso and Summit’s ivonescimab extended survival in a China-based Phase 3 study in previously untreated squamous NSCLC, delivering a 34% risk reduction in death versus standard immunotherapy plus...

FDA user-fee negotiations for the next cycle moved into White House review, according to sources describing scrutiny of a deal that sets prescription drug user fees for 2028 through 2032. The...

FDA is set for a busy June with 11 upcoming PDUFA dates, including a late-month decision that could expand the label of Ionis Pharmaceuticals’ Tryngolza olezarsen. The antisense oligonucleotide...

Pfizer and Innovent Biologics inked an up-to-$10.5 billion global licensing and collaboration agreement covering 12 early-stage and de novo antibody and ADC programs, marking another major move by...

BioNTech/Bristol Myers Squibb and Pfizer are taking different approaches to overall survival in first-line NSCLC trials aimed at building the next PD-(L)1×VEGF bispecific franchise, according to...

CareTria acquired CaryHealth to build an AI direct-to-patient pharmacy platform focused on reducing friction between prescribing and therapy initiation. The combined offering merges CareTria’s...

Allogene Therapeutics announced a CEO transition with Zachary Roberts set to succeed David Chang as president and CEO on July 1. Roberts, currently EVP of R&D and Chief Medical Officer at the...

Biohub researchers released an AI-generated protein atlas dubbed the ESM Atlas, predicted to cover more than one billion protein structures along with billions of sequences, vastly expanding on...

ASCO said it will not recommend Grail’s Galleri test for population cancer screening after reviewing results from the NHS-Galleri trial. The decision follows questions about whether the trial’s...

Revolution Medicines’ daraxonrasib posted “landscape-changing” survival data at ASCO for metastatic pancreatic cancer driven by RAS G12 mutations, nearly doubling outcomes versus standard...

Akeso’s ivonescimab, developed with Summit Therapeutics, delivered a 34% death-risk reduction in previously untreated squamous non-small cell lung cancer in a China-based trial. The results,...