Latest Biotech News

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,...

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...