-
Regulatory Intelligence & Drug Approvals2 months agoActing CBER, CDER heads become permanent as FDA works to restore stability
The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton,...
-
Regulatory Intelligence & Drug Approvals2 months agoFDA starts review of AZ’s COPD blockbuster hope
The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
-
Regulatory Intelligence & Drug Approvals2 months agoFDA makes acting CDER, CBER chiefs permanent
Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.
-
Regulatory Intelligence & Drug Approvals2 months agoFDA grants RMAT designation to RiboX’s RXRG001 for xerostomia
RXRG001 is a circular ribonucleic acid (RNA) therapy encoding human aquaporin-1, a protein involved in fluid transport. The therapy is encapsulated within lipid nanoparticles and directly...
-
Regulatory Intelligence & Drug Approvals2 months agoFDA solidifies CDER, CBER leadership posts as commissioner confirmation awaits
In a stabilizing move, the Department of Health and Human Services announced Tuesday afternoon that it has tapped Michael Davis, M.D., Ph.D., and Karim Mikhail—who’ve been...
-
Regulatory Intelligence & Drug Approvals2 months agoUpcoming FDA approval decisions in Q4 2026
Nature Reviews Drug Discovery, Published online: 09 September 2026; doi:10.1038/d41573-026-00150-1Upcoming FDA approval decisions in Q4 2026
-
Regulatory Intelligence & Drug Approvals2 months agoSTAT+: FDA names acting heads of drug and vaccine centers to permanent roles
The moves bring stability to an agency that's been rocked by the exits of top leadership.
-
Regulatory Intelligence & Drug Approvals2 months ago
Quoin Pharmaceuticals Announces FDA Grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome
ASHBURN, Va., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare...
-
Regulatory Intelligence & Drug Approvals2 months agoSummary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker...
-
Regulatory Intelligence & Drug Approvals2 months agoSTAT+: FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandals
The FDA warned a supplier of active pharma ingredients about residue on walls, a corroded product line, and open-toed sandals at its facility. It also included...
LncRNA SBF2-AS1 Worsens Heart Injury After Attack via miR-149-5p/PHLPP2 Axis
Stigmatizing language found in over half of primary care patient records
Research report: The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
