Latest Biotech News

Puxitatug samrotecan (AZD8205) generated high response rates in B7-H4–selected recurrent or progressive endometrial cancer in the BLUESTAR Phase 1/2a program, including a 47.1% confirmed objective...

Bristol Myers Squibb unveiled Phase 3 results for mezigdomide plus carfilzomib and dexamethasone (MeziKd) in relapsed or refractory multiple myeloma under its SUCCESSOR-2 program. The mezigdomide...

Pfizer reported detailed Phase 3 TALAPRO-3 results showing talazoparib (TALZENNA) plus enzalutamide (XTANDI) improved radiographic progression-free survival in HRR gene–altered metastatic...

ASCO said it will not recommend Grail’s Galleri test for population screening after the NHS-Galleri trial failed to meet its primary endpoint. The decision comes as the controversy continues over...

A SWOG prospective cohort study reported interim results on microRNA-371a-3p (miR371) as a relapse predictor in early-stage testicular cancer patients managed with active surveillance. The...

The White House is reviewing a new FDA user fee deal that would set prescription drug user fees for 2028 through 2032, according to sources cited in the report. The development adds another...

Pfizer struck a major oncology licensing collaboration with China’s Innovent Biologics covering 12 antibody-drug conjugates and multispecific programs, including eight Innovent early-stage assets...

Allogene Therapeutics announced that its chief medical officer, Zachary Roberts, will succeed David Chang as president and CEO on July 1, with Roberts joining the board while Chang remains on the...

FDA approval for a tumor-only next-generation sequencing approach for solid tumors marks a practical shift in how comprehensive genomic profiling can be deployed in routine care. Tempus AI said...

Pfizer and Innovent Biologics escalated their global oncology collaboration with a deal sized up to $10.5 billion, anchoring the partnership around next-generation antibody-drug conjugates and...

The next cycle of FDA prescription drug user fee negotiations is moving through the White House review process, according to sources. The deal sets user fee levels for the agency from 2028 through...

ASCO said it will not recommend Grail’s Galleri MCED test for use in cancer screening after reviewing results from the NHS-Galleri randomized trial. The trial did not meet its primary endpoint of...

Bristol Myers Squibb reported Phase 3 success for mezigdomide as an add-on to standard relapsed or refractory multiple myeloma therapy. In the Successor-2 study, the mezigdomide plus carfilzomib...

Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for pancreatic cancer, CEO Mark Goldsmith said. The drug is still...

Giredestrant showed consistent invasive disease-free survival benefits across menopausal subgroups in ER+/HER2− early breast cancer, according to results from the lidERA trial presented at ASCO....

Replimune is lining up a new U.S. Food and Drug Administration resubmission for its advanced melanoma drug RP-1 after reaching alignment with the agency, following two prior rejections. The...

Cepheid’s point-of-care molecular vaginitis assay improved diagnostic accuracy in a randomized clinical study, driving more appropriate treatment at the first visit. In work from the University of...

In a SWOG prospective cohort, microRNA 371a-3p (miR371) predicted relapse risk in early-stage testicular cancer, but experts flagged uncertainty about clinical utility. Interim results from the...

The White House is reviewing the next FDA user-fee agreement covering 2028 through 2032, according to sources. The prospective deal would determine how much the biopharma industry pays the agency...

Bristol Myers Squibb reported Phase 3 results showing its CELMoD mezigdomide, added to carfilzomib plus dexamethasone, cut the risk of progression or death by 52% in relapsed or refractory...