Latest Biotech News

Bristol Myers Squibb advanced mezigdomide in multiple myeloma with Phase 3 data showing a delayed progression-or-death outcome versus carfilzomib and dexamethasone alone in the SUCCESSOR-2...

Pfizer reported detailed Phase 3 TALAPRO-3 results showing TALZENNA (talazoparib) plus XTANDI (enzalutamide) improved radiographic progression-free survival in men with homologous recombination...

Replimune is moving into a third attempt at FDA approval for its melanoma drug RP1 after reaching alignment with the agency on resubmission. The company said it will resubmit the biologics...

The next FDA prescription drug user fee package for 2028–2032 is under White House review, according to sources familiar with the process. The reported examination centers on the deal reached by...

ASCO declined to recommend Grail’s Galleri for cancer screening after reviewing data from the NHS-Galleri randomized trial, which failed to meet its primary endpoint. The guidance decision came...

China’s National Medical Products Administration (NMPA) issued final implementation measures for drug trial data protection, a step aimed at tightening rules around pharmaceutical intellectual...

Pfizer struck a multi-program oncology collaboration with Innovent Biologics worth $650 million upfront and up to $9.85 billion in milestones, covering early-stage and discovery antibody-drug...

Allogene Therapeutics announced a leadership transition that will replace President and CEO David Chang with Zachary Roberts, Allogene’s current EVP of R&D and CMO. The company said Roberts will...

The White House has begun reviewing a next FDA prescription drug user-fee deal covering 2028 through 2032, according to sources familiar with the discussions. The proposal sets the funding...

ASCO said it will not recommend Grail’s Galleri multicancer early detection test for routine use after reviewing follow-on evidence from the NHS-Galleri randomized trial. The trial did not meet...

Revolution Medicines started shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for pancreatic cancer. CEO Mark Goldsmith told STAT the company is now...

Pfizer and Innovent Biologics announced a collaboration valued at up to $10.5 billion, covering a portfolio of 12 early-stage and de novo antibody-drug conjugates and multispecific oncology...

Allogene Therapeutics said Zachary Roberts will succeed David Chang as president and CEO on July 1. Roberts will also join the board and currently serves as EVP of R&D and CMO at the off-the-shelf...

Legend Biotech founder Frank Fan is returning to ASCO with a new CAR-T platform plan aimed at high-yield manufacturing and non-gene-editing approaches, according to reporting on his new ambition....

Bristol Myers Squibb presented Phase 3 results for mezigdomide in the SUCCESSOR-2 study in relapsed or refractory multiple myeloma. In the trial, adding mezigdomide to carfilzomib and...

Giredestrant showed invasive disease-free survival benefits across menopausal status in lidERA, a randomized trial in high-risk stage I–III ER+/HER2− early breast cancer. The study compared...

Puxitatug samrotecan, a B7-H4-directed antibody-drug conjugate, produced high response rates in B7-H4-expressing recurrent or progressive endometrial cancer in the BLUESTAR phase 1/2a trial. At...

Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, expanding how clinicians can profile solid tumors with comprehensive genomic...

Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for advanced pancreatic cancer, with the drug still unapproved. The step...

New interim and subgroup results from the lidERA Phase 3 trial show giredestrant reduced invasive disease or death versus standard-of-care endocrine therapy across both premenopausal and...