Latest Biotech News

The FDA approved Arvinas and Pfizer’s PROTAC vepdegestrant (Veppanu) for a defined group of adults with metastatic estrogen receptor-positive, HER2-negative breast cancer whose disease has...

Rigel Pharmaceuticals published the final data from its Phase 1/2 ARROW study of pralsetinib (Gavreto) in metastatic RET fusion-positive NSCLC in the Journal of Clinical Oncology. The report adds...

The FDA rejected Replimune Group’s oncolytic immunotherapy RP1 twice despite earlier ‘breakthrough therapy’ designation based on promising trials in melanoma. The company is still pursuing...

Axsome Therapeutics won FDA approval to expand Auvelity’s label to include Alzheimer’s disease agitation. The approval provides access for patients with a condition affecting up to about...

Seaport Therapeutics began trading on the Nasdaq after executives rang the opening bell, following its initial public listing. The company is associated with a leadership bench largely drawn from...

Hemab Therapeutics priced an upsized IPO at $18 per share to raise gross proceeds of about $301.5 million, at the high end of its range. The company is set to begin trading on Nasdaq under ticker...

Sonire Therapeutics started its U.S.-based Sunrise II study of Suizenji, an ultrasound-guided high-intensity focused ultrasound (HIFU) system intended to ablate pancreatic tumors. The trial...

Cytiva and Rockwell Automation launched the figurate SCADA system to reduce digital bottlenecks across biopharmaceutical manufacturing. The platform is designed to integrate equipment and data...

Weill Cornell Medicine researchers reported preclinical evidence that activated T cells secrete extracellular vesicles containing DNA that can enter tumor and immune cells to stimulate antigen...

Industry-focused reporting highlighted that gene therapy has moved into a phase defined as much by manufacturing and safety systems as by clinical breakthroughs. The article argues that scalable...

The FDA approved Arvinas and Pfizer’s PROTAC breast cancer therapy Veppanu (formerly vepdegestrant) for a defined subgroup of adults with metastatic estrogen receptor-positive, HER2-negative...

Axsome Therapeutics’ Auvelity expanded its U.S. label to include Alzheimer’s disease agitation, giving the company access to a second major FDA-approved indication for its...

Rigel Pharmaceuticals published final Phase 1/2 ARROW data for pralsetinib (GAVRETO) in metastatic RET fusion-positive non-small cell lung cancer in the Journal of Clinical Oncology, extending...

The FDA twice declined to approve Replimune Group’s RP1 oncolytic immunotherapy program for melanoma despite earlier breakthrough therapy designation and fast-track signals. Replimune’s CEO,...

GoodRx expanded access to oral semaglutide for type 2 diabetes patients through its prescription savings platform, offering self-pay pricing with three monthly dosage tiers. The company said...

Canada approved a generic version of Novo Nordisk’s Wegovy/Ozempic semaglutide, produced by Dr. Reddy’s Laboratories, positioning the country as the first G7 market to offer a semaglutide generic....

Three biotechs priced upsized initial public offerings, raising more than $850 million combined, according to market reporting. The batch included Seaport Therapeutics and Hemab Therapeutics,...

Hemab Therapeutics Holdings priced an upsized IPO of 16.75 million shares at $18 per share, targeting gross proceeds of $301.5 million with additional potential proceeds from overallotment. The...

Hypervision Surgical raised £17 million (about $23 million) in a Series A financing to scale its hyperspectral imaging platform for surgical use. The system combines spectral sensing with...

Johnson & Johnson discontinued two CAR-T programs in B cell lymphoma, ending development of JNJ-9530 and JNJ-4496 amid a changing treatment landscape that has rapidly expanded with approvals of...