The Trump administration’s broad slash to university research budgets raises pertinent questions over impacts to the biopharma ecosystem, specifically how a changed trajectory of early research ...

Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S ...

Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, ...

In a paradigm shift from private-sector partners, the U.S. Department of Health and Human Services (HHS) and the NIH announced May 1 the development of Generation Gold Standard, a next-generation, ...

Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 ...

Presentations at Heart Rhythm 2025 for Field Medical Inc. and Adagio Medical Holdings Inc. demonstrated success in two very ...

The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that has plenty of competition. The human Fc receptor ...

Scientists at Institut Pasteur have gained new insights into how some people control HIV-1 replication after interruption of antiretroviral treatment (ART). The investigators found a fingerprint ...

Regulus Therapeutics Inc. CEO Jay Hagan told investors in a January call the company had no interest in “simply out-licensing” rights to lead candidate farabursen, an oligonucleotide targeting ...

The U.S. Securities and Exchange Commission said it obtained a judgment for a total of $17 million in penalties and disgorgement from a group of individuals and entities charged with investor fraud.

South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s ...

Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients ...