Latest Biotech News

The FDA cleared Arvinas’ PROTAC therapy Veppanu (formerly vepdegestrant) for a defined subgroup of adults with metastatic estrogen receptor-positive, HER2-negative breast cancer harboring ESR1...

Axsome Therapeutics’ Auvelity gained U.S. FDA approval for treating agitation in Alzheimer’s disease, expanding the drug’s label beyond its existing major depressive disorder indication. The...

GoodRx said it is expanding access to oral Ozempic (oral semaglutide) for self-pay type 2 diabetes patients through its prescription savings platform. The company described nationwide pricing of...

Canada approved a generic semaglutide product for sale, creating what the government described as the first G7 pathway for generic competition to Novo Nordisk’s Wegovy/Ozempic. The generic,...

Moderna said it is in talks with the FDA over Phase 4 COVID-19 vaccine data that could restore broader use after regulators narrowed the label last year. The company framed the work as supplying...

Hemab Therapeutics priced an upsized initial public offering, selling 16.75 million shares at $18 per share to raise $301.5 million in gross proceeds, with an additional $45 million possible if...

Seaport Therapeutics joined Nasdaq on May 1 after its parent, Puretech Health, moved to exit the U.S. market in favor of a sole listing on the London Stock Exchange. Seaport raised gross proceeds...

The FDA said Katherine Szarama will take over as acting director of the Center for Biologics Evaluation and Research (CBER) following Vinay Prasad’s departure from the agency. HHS confirmed the...

Researchers reported a DNA-guided CRISPR–Cas12a system that can recognize and cleave RNA targets using DNA as the programming layer. The platform, described as an activation architecture distinct...

Cytiva and Rockwell Automation launched Figurate SCADA, a supervisory control and data acquisition system aimed at reducing integration bottlenecks in biopharmaceutical manufacturing. The system...

Axsome Therapeutics’ Auvelity won FDA approval for Alzheimer’s disease agitation, giving the company access to a large commercial market tied to a population of patients with agitation symptoms....

Canada approved a generic semaglutide for sale in the country, marking the first G7 offering of a generic version of Novo Nordisk’s Wegovy/Ozempic. The product is produced by Dr. Reddy’s...

The FDA’s Center for Biologics Evaluation and Research (CBER) is entering a transitional phase as Vinay Prasad steps aside and Katherine Szarama takes over as acting director. The change follows...

A U.S. FDA oncology advisory panel voted against a “new paradigm” for AstraZeneca’s oral SERD camizestrant, declining to find a clinically meaningful benefit in the proposed setting. The panel’s...

Regulatory and capital-market developments converged with today’s focus on Alzheimer’s agitation. Alongside Auvelity’s FDA approval, the market digest included multiple financing and deal...

Johnson & Johnson discontinued two CAR-T programs in B-cell lymphoma, citing portfolio priorities and an evolving treatment landscape. The company said it is scrapping JNJ-9530 and JNJ-4496,...

U.S. lawmakers advanced a bill that would cut science spending while signaling resistance to the broader scale of the Trump administration’s original proposal. In the House Appropriations...

Axsome’s Auvelity cleared FDA approval for Alzheimer’s agitation, joining the company’s existing Alzheimer franchise and extending access for patients with agitation symptoms. In parallel,...

Bio-manufacturing and cell therapy infrastructure are getting more attention as programs scale, with emphasis on reducing time, variability, and regulatory risk during handoffs from research-grade...

Avalyn Pharma priced an upsized $300 million IPO to fund late-stage studies of inhaled respiratory drugs already on market for fibrosis. The company’s plan includes advancing inhaled...