Latest Biotech News

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...

The U.S. Food and Drug Administration approved Arvinas and Pfizer’s Veppanu (vepdegestrant) for metastatic ER-positive, HER2-negative breast cancer with ESR1 mutations that progressed after at...

Rigel Pharmaceuticals published final Phase 1/2 ARROW study data for its once-daily oral RET inhibitor pralsetinib (GAVRETO) in RET fusion-positive metastatic non-small cell lung cancer. The...

Vinay Prasad stepped aside as director of the FDA’s Center for Biologics Evaluation and Research (CBER), with Katherine Szarama, Ph.D., taking over as acting director while regulators search for a...

A new report on RP1, an oncolytic immunotherapy from Replimune Group, details why the FDA twice declined to approve the melanoma drug despite breakthrough therapy designation and early trial...

Seaport Therapeutics and Hemab Therapeutics continued the IPO resurgence with upsized offerings. Seaport joined Nasdaq on May 1 with gross proceeds of $254.9 million, while Hemab priced a $301.5...

Infinite Epigenetics agreed to acquire Tally Health, a move aimed at building a diagnostics-to-intervention platform spanning epigenetic testing, adult DNA methylation datasets, and personalized...

Guardant Health disclosed that Craig Eagle, the company’s chief medical officer, will resign effective May 8. Eagle previously held oncology medical affairs roles at Genentech (Roche) and...

Researchers at UC San Diego reported in a Cell paper that restoring protein recycling can reverse aspects of T-cell exhaustion in mice. The study, led by work from the lab of Ananda Goldrath,...

Cytiva and Rockwell Automation launched Figurate SCADA, aimed at reducing digital bottlenecks across biopharmaceutical manufacturing. The system is positioned as open-architecture supervisory...

Oregon Health & Science University (OHSU) researchers developed a nanoparticle-based approach designed to improve early detection of pancreatic cancer. The article highlights the clinical problem...

The FDA approved Arvinas and Pfizer’s Veppanu (formerly vepdegestrant), a proteolysis-targeting chimera (PROTAC), for a biomarker-defined subgroup of adults with metastatic estrogen...

FDA has twice declined to approve Replimune Group’s oncolytic immunotherapy RP1, despite the program receiving breakthrough therapy designation and fast-track attention after early trial results....