Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

Inluriyo, an oral estrogen receptor antagonist, significantly reduced disease progression risk in ESR1-mutated metastatic breast cancer, as shown in the EMBER-3 trial. Keytruda Qlex, a subcutaneous ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...