Latest Biotech News

Telix Pharmaceuticals agreed to acquire ITM Isotope Technologies Munich in a deal valued at up to $2.35 billion, aiming to secure isotope supply and expand radiopharmaceutical manufacturing...

Celldex Therapeutics’ Phase 3 program for barzolvolimab in chronic spontaneous urticaria advanced with efficacy, but safety questions emerged after the company reported two life-threatening...

Otsuka and Ionis Pharmaceuticals said a Phase 3 ALS study hit its primary endpoint, positioning the partners to discuss expedited regulatory pathways. The program uses the RNA-based candidate...

Beacon Therapeutics reported that its X-linked retinitis pigmentosa gene therapy laruparetigene zovaparvovec (laru-zova) met the FDA-endorsed primary endpoint in a pivotal Phase II/III trial. The...

Boehringer Ingelheim and Envisagenics announced a multi-target oncology collaboration with potential payments of more than $1 billion. The partnership leverages Envisagenics’ AI-driven RNA...

Cue Biopharma’s Phase 2 update in chronic spontaneous urticaria (CUE-221) showed performance in moderate-to-severe CSU, but shares fell sharply as investors digested the implications for the...

The U.S. FDA issued a final rule intended to provide more flexibility in preclinical safety development by clarifying that nonanimal methods can be used where appropriate for assessing safety of...

Iambic Therapeutics filed for an IPO, adding to the wave of AI-focused biotech startups seeking public-market funding. The San Diego-based company disclosed details on pipeline programs and...

Andelyn Biosciences said it is manufacturing Fayuvi (rebisufligene etisparvovec-hopf) for commercial supply, following the FDA approval of the Sanfilippo syndrome type A gene therapy developed by...

Two FDA-linked rare-disease milestones landed this week, underscoring regulators’ growing comfort with expedited pathways in high-unmet-need areas. IntraBio’s Aqneursa (levacetylleucine) received...

Radiopharma dealmaking intensified as Telix agreed to buy ITM Isotope Technologies Munich in an all-stock transaction worth $1.65 billion upfront, with potential milestone consideration that can...

Beacon Therapeutics’ gene therapy for X-linked retinitis pigmentosa continued to advance after meeting its FDA-endorsed primary endpoint in a pivotal Phase 2/3 trial. The company reported that...

Boehringer Ingelheim signed a potential $1 billion multi-year collaboration with Envisagenics to validate tumor-specific targets using the Envisagenics RNA splicing platform. The pact centers on...

Roche’s metabolic pipeline took another step as a Phase 2 trial of its dual GLP-1/GIP receptor agonist hit primary endpoints in people with type 2 diabetes and overweight or obesity. The company...

Cue Biopharma’s chronic spontaneous urticaria program received mid-stage reinforcement after a Phase 2 readout of CUE-221 in moderate-to-severe disease. The study met key efficacy targets,...

The FDA unveiled a pilot program designed to expedite Phase I trial initiation by pairing sponsors with prequalified research institutions. Under the model, the agency will select eight to ten...

Iambic Therapeutics combined AI platform momentum with Big Pharma collaboration efforts by signing an R&D partnership with AbbVie while releasing a next-generation model update for its Enchant...

Canada’s Stem Cell Network made its first direct company investment, awarding $1 million to Montreal-based RejuvenRx through a new Incubation Investment Award. The program targets an early-stage...

Intermountain Health reported operational gains after implementing AI tools for clinical documentation improvement, citing a 22 percentage-point increase in inpatient chart completion during or...

Telix Pharmaceuticals agreed to acquire ITM Isotope Technologies Munich in an all-stock deal valuing ITM at about $1.65 billion upfront, with potential milestone payments that could take the total...