-
Regulatory Intelligence & Drug Approvals1 week agoPfizer’s Talzenna Plus Xtandi FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting
NEW YORK--(BUSINESS WIRE) October 26, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has expanded approval of Talzenna...
-
Regulatory Intelligence & Drug Approvals1 week agoVaginal microbiome shows promise for predicting HPV clearance after HSIL treatment
A scoping review links Lactobacillus-dominant vaginal communities with HPV clearance after HSIL therapy while finding that dysbiosis, methodological gaps and small peri-treatment studies prevent clinical use.
-
Regulatory Intelligence & Drug Approvals1 week agoMultimedia Education Materials | Biosimilars
FDA offers a variety of materials in multiple formats to help promote understanding of biosimilars and interchangeable products.
-
Regulatory Intelligence & Drug Approvals1 week ago9 Things to Know About Biosimilars and Interchangeable Biosimilars
FDA experts share some interesting facts about to biosimilars and interchangeable biosimilars.
-
Regulatory Intelligence & Drug Approvals1 week agoFDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations
On October 26, 2026, the Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for the treatment of adults with metastatic...
-
Regulatory Intelligence & Drug Approvals1 week agoSTAT+: GSK sees its return to cancer start to pay off
A decade ago, GSK was out of oncology. It could soon pick up approval for its sixth cancer drug.
-
Regulatory Intelligence & Drug Approvals1 week agoFDA Drug Topics Webinars
FDA’s Office of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care...
-
Regulatory Intelligence & Drug Approvals1 week agoStatement on improving adverse event reporting of compounded drugs to protect patients
The FDA is working to improve adverse event reporting of compounded drugs to protect patients
-
Regulatory Intelligence & Drug Approvals1 week agoSTAT+: Five biotech updates to read after ESMO this weekend
Moderna and Merck are racing to submit their personalized cancer vaccine for FDA approval, expected in 2027, according to Moderna CEO Stéphane Bancel.
-
Regulatory Intelligence & Drug Approvals1 week ago
Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein, a First-in-Class Adjunct in the Real-Time Intraoperative Visualization of Nerves During Head and Neck Surgical Procedures in Adults
SAN DIEGO--(BUSINESS WIRE) September 25, 2026 --Alume Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for...
RNA-protein interactions could lead to new coronavirus drug targets
A CRISPR gene boost reduces seizures and strengthens muscles in mice
Automated platform optimizes enzyme production using cell-free protein synthesis and AI-driven design
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
