FDA News

BOSTON--(BUSINESS WIRE)--Foundation Medicine launches FoundationOne®MRD, a molecular residual disease (MRD) test....

BOCA RATON, Fla.--(BUSINESS WIRE)--SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ION-C™ navigation instruments for use with the ION-C™ posterior cervical facet fixation implant. The system is engineered for comp...

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Beren Therapeutics P.B.C., the parent company of Mandos LLC and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, today announced that the company will present six posters at the 2026 Michael, Marcia, and Christa Parseghian Scientific Conference for Niemann-Pick Type C Research, sponsored by the family of former Notre Dame head football coach Ara Parseghian, taking place May 30 through June 2 in Tucson, Arizona. The posters...

TORONTO--(BUSINESS WIRE)--Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (OTC: MVMDF) is pleased to report on the advancement of its patented Quicksome™ sublingual delivery platform as part of the Company’s strategy to position Quicksome™ as a differentiated delivery solution within the evolving compounded peptide marketplace across North and South America. Over the past six months, the Company has expanded its internal formulation capabilities following investments in l...

CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a tumor-only indication for its xT CDx next-generation sequencing platform. With this expanded label, Tempus is the first laboratory to hold FDA companion diagnostic (CDx) approval for both tumor-only and tumor-normal comprehensive genomic profiling. Tempus xT CDx is a 648...

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced FDA approval of ECoG Assistant, its first AI-driven clinician-enabled feature. This milestone represents an important step in NeuroPace’s broader AI platform strategy, leveraging the world’s only long-term intracranial EEG dataset to transform how epilepsy is monitored and managed. ECoG Assistant: Treatment Insights Si...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced unprecedented seven-year follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). At seven years, patients treated with LORBRENA had a 55% likelihood of re...

AUSTIN, Texas--(BUSINESS WIRE)--PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage company redefining early cancer treatment with therapeutic implants administered directly at the tumor site, today announced that it has concluded the dose escalation portion of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC). PanTher has identified the PTM-101 400mg paclitaxel-containing implant as the recommended Phase 2 dose (RP2D) in combination with neoadjuv...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and e...

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, is advancing the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA® (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further suppo...