Latest Biotech News

The U.S. FDA approved 24 drugs in May 2026, making it the busiest month of the year so far and lifting year-to-date approvals to 84. Of the 24 clearances, 20 were new molecular entities, according...

AbbVie agreed to acquire Apogee Therapeutics for about $10.9B, targeting the atopic dermatitis drug candidate zumilokibart (APG777) as a potential long-acting immunology product with broader...

Pfizer’s first new antibody-drug conjugate (ADC) to report pivotal Phase 3 results after the Seagen acquisition missed its primary endpoint in non-small-cell lung cancer. The ADC, sigvotatug...

China’s NMPA approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The Claudin18.2-targeted,...

Regenxbio said the FDA will reconsider its Hunter syndrome gene therapy after the agency reversed course following rejection. The company plans to resubmit its application for RGX-121, with...

Denali Therapeutics sold a priority review voucher for $195 million to support its neurodegenerative and lysosomal pipeline. The voucher was issued after FDA approval of Avlayah for Hunter...

Osanni Bio raised $190 million in a Series B to build ophthalmology- and cardiology-focused “affiliate companies,” designed to expand clinical and translational efforts across multiple programs....

VectorBuilder and MaxCyte formed a strategic partnership to co-develop a clinical-grade, next-generation nonviral gene delivery system for ex vivo cell engineering. The collaboration combines...

Serapha Bio launched after completing a reverse merger and raising $230 million in funding commitments, anchored by RA Capital and RTW Investments. The new company is building an in vivo base...

HHS unveiled a blueprint to speed up early-stage drug development, targeting first-in-human timelines by reducing documentation burden for Investigational New Drug (IND) applications and creating...

AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion in cash, aiming to extend its immunology pipeline with long-acting assets, led by zumilokibart (IL-13). The deal values Apogee...

China approved CARsgen’s satricabtagene autoleucel (satri-cel) for solid tumors, marking what the company says is the first CAR-T authorization in the category for a specific solid-tumor target....

Pfizer’s first new antibody-drug conjugate (ADC) to read out pivotal data after its Seagen acquisition stumbled in a Phase 3 non-small cell lung cancer trial. The failure of sigvotatug vedotin in...

Eli Lilly’s retatrutide program is drawing attention not only for its clinical promise but also for how access is being handled before regulatory clearance. According to STAT+, Lilly and the FDA...

Leica Biosystems and Versant Diagnostics expanded their collaboration as PRW Laboratories became the first lab network to deploy Leica’s Aperio GT Elite solution. The high-throughput scanner is...

Medable launched its Digital Data Flow (DDF) Agent to convert static clinical trial protocols into machine-readable, standardized data in CDISC USDM 4.0 JSON format. The company says the agent can...

AbbVie’s immunology strategy moved further into clinical execution via its acquisition deal, but separate immunology progress continues across multiple companies. Merck reported a positive...

Regenxbio said it will resubmit its Hunter syndrome gene therapy application after FDA personnel reversed an earlier position about needing a placebo-controlled component. The company said FDA...

Lys Therapeutics advanced its lead candidate toward the clinic with support of more than €25 million raised since inception, including over $5 million from the Michael J. Fox Foundation. The...

AbbVie agreed to buy Apogee Therapeutics in a roughly $10.9 billion cash deal, taking the atopic dermatitis and asthma-focused pipeline into its immunology franchise. The centerpiece is...