Potentially accelerates development, assessment, and review for approval by FDA Sepsis impacts about 1.7 million U.S. adults ...

New medical devices deemed "breakthrough" by the FDA are no longer automatically eligible for extra Medicare payments.

Three months ago, Nuvectis Pharma (NASDAQ: NVCT) was an oncology developer anchored by a single early-stage program. Today it holds ex-China rights to the world's first approved once-daily oral Factor ...

Please provide your email address to receive an email when new articles are posted on . The drug, a formulation of LSD, previously received breakthrough therapy designation related to generalized ...

Novo Nordisk and Eli Lilly say GLP-1 drugs slowed aging clocks, but the data are early and unreviewed. Here is what patients should know. A study of 1.4 million women links pregnancy complications to ...

The Breakthrough Therapy Designation is based on data from the open-label, multicenter Phase 1/2 RMC-GI-102 trial of RASONQUE in combination with GnP in patients with treatment-naïve, RAS-mutant ...

The FDA granted breakthrough therapy designation to daraxonrasib/chemotherapy for treatment-naive pancreatic adenocarcinoma based on phase 1/2 trial data. The FDA has ...

Revolution Medicines received breakthrough therapy designation from the Food and Drug Administration for its treatment of pancreatic cancer. The designation is for Rasonque to treat metastatic ...

Company receives third Breakthrough Therapy Designation for RASONQUE and fifth across its portfolio of RAS(ON) inhibitors, further highlighting its differentiated strategy for developing innovative ...

LOS ANGELES, Sept. 14, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company focused on the development of ...

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Nutromics' microneedle wearable patch for vancomycin therapeutic drug monitoring. Approximately 2.9 million ...