Takeaways: ‘FDA Watch’ Series Examines the Intersection of Regulatory Operations, M&A and Litigation and the Resulting Shifted... JD Supra 22:52 Tue, 23 Jun
Life Spine Receives FDA 510(k) Clearance for VersaLift™ Expandable Interbody System Featuring a 6mm Starting Height Business Wire (Press Release) 22:47 Tue, 23 Jun
What a $350,000 Insider Sale Might Mean for Mineralys Ahead of December FDA Decision The Motley Fool 22:29 Tue, 23 Jun
Agomab Therapeutics Aligns With FDA On Design Of Phase 2b Nov-era Study With Ontunisertib Benzinga 21:26 Tue, 23 Jun Article paywall
FDA Reverses Course on Neuro Drugs; Omega-3s and Dementia; Brain Death Test Lawsuit Medpage Today 19:21 Tue, 23 Jun
FDA Expands TOFIDENCE® (tocilizumab-bavi) Label to Include CRS and COVID-19 JD Supra 17:55 Tue, 23 Jun
Pathway Labs Announces World's First FDA Clearance for Multicondition AI in Cardiology and Partnership with OpenEvidence Business Wire (Press Release) 17:25 Tue, 23 Jun
FDA, EMA to Review Cemdisiran Regulatory Submissions in AChR-Positive Myasthenia Gravis Rare Disease Advisor 17:10 Tue, 23 Jun
‘We’re prepared for whatever the FDA wants’: A vaccine developer gets back on track Chemical & Engineering News 17:05 Tue, 23 Jun
PorTal Access secures FDA clearance for vascular access ports Verdict Medical Devices 16:30 Tue, 23 Jun
FDA Approves First Over-the-Counter Glucose Monitor for Children Dermatology Advisor 15:23 Tue, 23 Jun
FDA changes rare disease tune again as it clears path for Regenxbio’s gene therapy Pharmaceutical Technology 15:09 Tue, 23 Jun
FDA Approves the HepQuant shunt® Liver Diagnostic Test to Quantify Risk of Large Esophageal Varices in Adult Patients with Compensated Cirrhosis (Child Pugh Class A) Business Wire (Press Release) 14:38 Tue, 23 Jun
FDA Approves Capvaxive Pneumococcal Conjugate Vaccine for At-Risk Children Infectious Disease Advisor 14:36 Tue, 23 Jun
FDA Clears Generic Baloxavir Marboxil Ahead of 2026-2027 Flu Season Infectious Disease Advisor 14:36 Tue, 23 Jun
STAT Plus: Pharmalittle: We’re reading about FDA reforming clinical trials, a Pfizer setback, and much more news STAT 14:28 Tue, 23 Jun
Quoin Pharma: FDA Conditionally Accepts Qyleki As Proposed Brand Name For QRX003 RTT News 14:20 Tue, 23 Jun
FDA Outlines New Actions to Accelerate and Modernize Clinical Drug Development American Pharmaceutical Outsourcing (Press Release) 14:12 Tue, 23 Jun
FDA To Slash Early Clinical Trial Timelines By 6-12 Months In New HHS Initiative The Dallas Express 14:05 Tue, 23 Jun
Medication abortion: Decisions from federal courts, the FDA or Trump’s Department of Justice could try to end access via telehealth The Conversation (US) 13:30 Tue, 23 Jun
BioMendics Receives FDA Fast Track Designation for BM-3103 (TolaSure® Gel™) for Epidermolysis Bullosa Simplex Business Wire (Press Release) 13:06 Tue, 23 Jun
Calico Life Sciences Announces Fosigotifator Granted Breakthrough Therapy Designation by the U.S. FDA for the Treatment of Vanishing White Matter Disease PR Newswire (Press Release) 13:01 Tue, 23 Jun
Ascletis Receives FDA Ind Clearance To Begin Phase I Trial Of Once-Monthly Obesity Drug ASC35 RTT News 12:37 Tue, 23 Jun
Masimo secures FDA approval for OIRD detection on wearable patient monitor Verdict Medical Devices 12:15 Tue, 23 Jun
FDA monitoring failures cited in nearly a third of pharmaceutical warning letters and rising, according to Eupry PR Newswire (Press Release) 11:28 Tue, 23 Jun
Ascletis Announces U.S. FDA Ind Clearance for Phase I Study of Once-Monthly Subcutaneously Administered GLP-1R/Gipr Dual Peptide Agonist, ASC35, for the Treatment of Obesity PR Newswire (Press Release) 11:13 Tue, 23 Jun