Latest Biotech News

China’s National Medical Products Administration (NMPA) issued final implementation measures for drug trial data protection, a move aimed at better aligning China’s pharmaceutical IP framework...

Rest Therapeutics’ investigational PTSD therapy, RST-101, cleared an early regulatory milestone as the U.S. FDA accepted its IND application. The acceptance supports the company’s plan to begin...

Tempus AI won FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform. The assay is positioned for comprehensive genomic profiling of solid tumors and acts as a...

AbbVie received U.S. FDA clearance for Decnupaz (pivekimab sunirine), a CD123-targeting antibody-drug conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval...

Replimune reached alignment with the FDA to resubmit its advanced melanoma therapy RP-1 (vusolimogene oderparepvec) after two previous complete response letters. The company said the FDA will...

CareTria acquired CaryHealth to build an AI direct-to-patient pharmacy platform designed to streamline prescription-to-therapy initiation and improve medication adherence workflows. The combined...

The White House is examining a new prescription drug user-fee agreement between the FDA and the biopharma industry that would set fee levels for 2028 through 2032. Sources indicate the framework...

CVS Caremark expanded access for Eli Lilly’s obesity drugs by placing Foundayo on formularies starting June 1 and restoring Zepbound as a preferred option on Oct. 1, while keeping Novo Nordisk’s...

GSK reported new late-stage hepatitis B data that it said supports a functional cure with bepirovirsen. In two Phase 3 trials in noncirrhotic chronic hepatitis B patients, GSK reported functional...

AbbVie won an FDA approval for Decnupaz (pivekimab sunirine) to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The antibody-drug conjugate is CD123-targeted and received...

Pfizer struck a broad multiyear collaboration with Innovent Biologics covering up to 12 early-stage cancer programs, including eight from Innovent and four discovery options proposed by Pfizer....

Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The tissue-based 648-gene test can be used for comprehensive genomic profiling in solid...

Delfi Diagnostics received approval from the New York State Department of Health to offer its FirstLook Lung blood-based laboratory-developed test for lung cancer screening. The approval allows...

Bristol Myers Squibb shared efficacy results for mezigdomide from the Phase 3 SUCCESSOR-2 trial in relapsed or refractory multiple myeloma. In the analysis of 479 patients, adding mezigdomide to...

Agios said it is ending development of tebapivat in low-risk myelodysplastic syndromes after Phase 2b results fell short. The pyruvate kinase activator, designed to improve cellular energy...

Quanterix appointed Andrew Catalano as chief operating officer, bringing prior operations experience from Akoya Biosciences, which Quanterix acquired in 2025. In parallel, Verge Labs—formerly...

Verge Genomics rebranded as Verge Labs and changed course following an early clinical trial failure for VRG50635 in ALS. The company said it laid off roughly 90% of staff after concluding the...

Countable Labs closed a $26 million financing round to scale commercial expansion of its single-molecule PCR technology. The company said it will also develop solutions for measurable residual...

AbbVie won FDA approval for its CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), following the company’s...

GSK reported Phase 3 results for bepirovirsen (B-Well 1 and B-Well 2) in chronic hepatitis B, saying 19% to 20% of treated patients achieved a functional cure after stopping nucleos(t)ide analog...