Promising Trial Data Lead to FDA Fast Track Designation for Breast Cancer Combination Therapy
FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative…
Beyond the Ordinary Beyond the Obvious
FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative…
Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev…
Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design. A study recently published in…
Published on: December 1, 2023 Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences highlights…
DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib…
Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam;…
The clearance includes the Vivos Therapeutics, Inc’s DNA oral appliance, the mRNA oral appliance, and the mmRNA oral…
Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically…
The Elecsys HBeAg quant can detect the presence and quantity of the hepatitis B e antigen (HBeAg) in…
Results from decade-long analysis suggest great improvement is needed in the quality of control groups. A study recently…