Latest Biotech News

The U.S. FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton) for adults with narcolepsy type 1, positioning the drug as the first therapy designed to address the underlying...

Transthera Sciences won NMPA approval in China for Yochanra (tinengotinib) in FGFR2-positive cholangiocarcinoma that progressed after FGFR inhibitor therapy. The designation targets a...

The DOJ Antitrust Division announced a return to targeted Second Request investigations under the Hart-Scott-Rodino Act, along with a model timing agreement. In practice, the agency says it will...

CMS proposed changes to the 340B Drug Pricing Program payment rates for drugs beginning in calendar year 2027, while HRSA updated its 340B Rebate Model Pilot Program. Together, the moves signal an...

NIAID awarded Zepto Life Technology a contract valued at up to $8.9 million to advance a plasma cell-free DNA liquid biopsy platform for invasive fungal infections. The funded work supports...

Bristol Myers Squibb selected Houston for a $2.3 billion multi-modal manufacturing campus intended to support drug product and finished-goods manufacturing across late development through launch....

A private financing roundup highlighted AI platform Chai and radiopharma startup Advancell among the top July raises, as biopharma deal value totaled $7.51 billion across 79 transactions in...

China reported another gene editing death tied to a young patient receiving HG-302 for Duchenne muscular dystrophy, according to disclosures by Huidagene Therapeutics. The report follows earlier...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences for up to $1.3 billion, with $820 million upfront, to expand its epilepsy pipeline. The deal is anchored by Actio’s lead program ABS-1230,...

K2 Therapeutics appointed Ying Huang as its new CEO, following his departure as CEO of Legend Biotech. K2 is positioning itself as a drug discovery search and licensing platform, seeking...

Epicrispr Biotechnologies secured $90 million in a Series C round after sharing early data for EPI-321, an epigenetic editing approach targeting facioscapulohumeral muscular dystrophy (FSHD). The...

Infinimmune launched its eczema push with a $75 million Series A, aiming to deliver next-generation biologics for atopic dermatitis that could improve on Dupixent’s pace and injection burden. The...

Sionna Therapeutics reported that its Phase 2 cystic fibrosis add-on pill, SION-719, failed to show benefit when added to Vertex’s Trikafta, prompting the biotech to stop advancing the program and...

Skylar Bio dosed its first patient in a new gene therapy effort for childhood hearing loss linked to GJB2 mutations, building on the field’s momentum after FDA approval of Regeneron’s...

The FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical candidate intended for neuroendocrine tumors, citing manufacturing problems that delayed a potential challenger to Novartis’...

Broken String Biosciences launched BaseMap ABE, a platform meant to standardize genome-wide off-target characterization for adenine base editing (ABE) therapeutic development. The company said the...

Labcorp received FDA approval for PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma, supporting patient selection for targeted therapies...

CMS issued proposed details for the RAPID pathway, an effort to reduce the gap between FDA breakthrough device approvals and Medicare coverage. The program is designed to address “coverage...

China tightened controls on clinical trials via a regulatory shift that is reshaping the country’s previously fast translation model. The reporting focuses on investigator-initiated trials (ITTs),...

Bristol Myers Squibb selected Houston as the location for a $2.3 billion multi-modal manufacturing campus supporting drug product and finished goods manufacturing from late development through...