Latest Biotech News

The FDA approved Pfizer and Arvinas’ protein-degrading breast cancer drug Veppanu (formerly vepdegestrant) for patients with metastatic, estrogen receptor-positive, HER2-negative breast cancer...

Rigel Pharmaceuticals published final Phase 1/2 ARROW study data in the Journal of Clinical Oncology for pralsetinib (Gavreto) in metastatic RET fusion-positive NSCLC, adding 42 months of...

The FDA has twice declined to approve Replimune Group’s oncolytic immunotherapy candidate RP1 for melanoma, despite the program previously receiving breakthrough therapy designation based on...

Axsome Therapeutics won FDA approval to expand Auvelity’s label to include Alzheimer’s disease agitation, giving the company a second FDA-approved indication for its dextromethorphan-bupropion...

Moderna said it is in talks with the FDA to provide Phase 4 post-marketing data that could restore broader use of its COVID-19 vaccines after regulators narrowed the labels last year. The...

Guardant Health said Chief Medical Officer Craig Eagle will resign effective May 8, marking a near-term leadership transition at the company focused on oncology liquid biopsy. Eagle previously...

Biocentury reported that three biotechs raised more than $850 million in upsized IPOs, supported by strong aftermarket trading. The slate includes follow-on activity driven by data readouts for...

Cytiva and Rockwell Automation launched Figurate SCADA, an open-architecture supervisory control and data acquisition system intended to connect biopharma manufacturing equipment and reduce...

A House appropriations subcommittee voted to cut U.S. science agency budgets, advancing a bill that would reduce the NSF’s 2027 spending by 20% and NOAA’s by 5%, while keeping total NASA funding...

Sonire Therapeutics started a U.S.-based Sunrise II study of its Suizenji ultrasound-guided high-intensity focused ultrasound (HIFU) system to ablate pancreatic tumors after closing an $18 million...

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

Rigel Pharmaceuticals published the final long-term results from the Phase 1/2 ARROW study of pralsetinib (Gavreto) in metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in the...

Replimune’s oncolytic immunotherapy RP1, engineered from a modified herpesvirus, has faced additional FDA hurdles after the agency declined approval twice despite the program holding breakthrough...

Three biotechs priced upsized IPOs in a single window, totaling more than $850 million combined, and moved into public trading with gains in the aftermarket. Seaport Therapeutics, Hemab...

Cytiva and Rockwell Automation launched Figurate SCADA, a supervisory control and data acquisition layer meant to reduce digital bottlenecks across biopharmaceutical manufacturing. The...

Guardant Health announced that Craig Eagle, the company’s chief medical officer, will resign effective May 8, after stints including Roche’s Genentech and Pfizer. Delfi Diagnostics appointed...

Johnson & Johnson scrapped two CAR-T cell therapy programs for B-cell lymphoma as the company cited an evolving market shaped by years of approvals across cell therapies and antibody-based...

Canada approved a generic semaglutide product as a Wegovy/Ozempic alternative, supplied by Dr. Reddy’s Laboratories and sold by prescription, making it the first G7 country to greenlight a...

A study from Weill Cornell Medicine reports that activated T cells secrete extracellular vesicles (EVs) containing DNA that can enter other immune and tumor cells to enhance antigen processing and...

Moderna said it is in talks with the FDA about Phase 4 Covid vaccine post-marketing data after regulators narrowed the label for the products last year. The company’s stated aim is to restore...