Latest Biotech News

The U.S. Food and Drug Administration signaled a policy shift by endorsing approval based on a single well‑controlled trial supplemented with confirmatory evidence, authors at the agency argued in...

The FDA released draft guidance detailing the ‘plausible mechanism’ pathway to advance individualized cell and gene therapies for extremely rare genetic conditions. The framework outlines the...

GSK struck a deal with China’s Frontier Biotechnologies, paying $40 million up front for two siRNA candidates and agreeing to nearly $1 billion in milestone payments plus tiered royalties....

Gilead Sciences licensed a clinic‑ready MAT2A inhibitor from Suzhou‑based Genhouse Bio in a deal valued at up to $1.53 billion. The program targets synthetic lethality approaches in oncology that...

Madrigal Pharmaceuticals added a siRNA approach to its NASH/MASH pipeline by acquiring six preclinical siRNA candidates from Ribo Life Science and Ribocure in a deal that could reach $4.4 billion...

Harbour Biomed announced the spin‑out of Solstice Oncology and outlicensed its CTLA‑4 antibody porustobart (HBM‑4003) to the new company in a transaction structured with cash and equity valued at...

BioMarin withdrew its hemophilia A gene therapy Roctavian from the market after failing to secure a buyer or partner to shoulder commercial and reimbursement risk. The decision follows public...

The U.S. Food and Drug Administration accepted Takeda’s new drug application for oveporexton (TAK‑681) with priority review, advancing the oral orexin receptor 2 agonist closer to approval for...

Gilead agreed to acquire Arcellx for $7.8 billion in cash plus a contingent payment structure, moving to full ownership of anitocabtagene autoleucel (anito‑cel), a BCMA‑directed CAR‑T therapy for...

Novo Nordisk reported that its next‑generation obesity candidate CagriSema failed to demonstrate non‑inferiority to Eli Lilly’s Zepbound in a head‑to‑head late‑stage trial, producing less weight...

The U.S. Food and Drug Administration published draft guidance formalizing a ‘plausible mechanism’ framework to accelerate approvals for individualized therapies targeting extremely rare genetic...

GSK struck a licensing and option deal with China’s Frontier Biotechnologies, paying $40 million upfront for two siRNA candidates and agreeing to up to $963 million in milestone payments plus...

Flagship Pioneering’s Generate Biomedicines is targeting a large public offering to fund late‑stage development, with reports indicating plans for a Nasdaq IPO that could value the company north...

Guardant Health agreed to acquire MetaSight Diagnostics for $59 million plus up to $90 million in milestones, adding mass‑spectrometry–based metabolomics and lipidomics to Guardant’s portfolio....

Sweden‑based Immedica secured accelerated approval from the FDA for a therapy addressing persistently elevated plasma arginine in ARG1‑D, a rare urea‑cycle disorder. The FDA’s action revives a...

Slate Medicines closed a $130 million Series A to advance a PACAP‑targeting migraine therapy licensed from Guangzhou‑based DartsBio Pharmaceuticals, seeking to develop a subcutaneous injection...

Budapest‑based Turbine raised $25 million in a Series B round to accelerate commercialization of its 'Virtual Lab' platform—AI models that simulate cellular behavior for drug discovery and lead...

Abcuro disclosed that its phase 2/3 trial of ulviprubart, an anti‑KLRG1 antibody for inclusion body myositis (IBM), failed to meet the study’s primary and key secondary endpoints in a 272‑patient...

Gilead agreed to acquire Arcellx for $7.8 billion to secure full control of anito‑cel, a BCMA‑directed CAR‑T therapy nearing regulatory review. The transaction, announced by Gilead and Arcellx,...

The U.S. Food and Drug Administration released draft guidance formalizing a 'plausible mechanism' pathway to accelerate individualized and ultrarare therapies that cannot rely on traditional...