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Regulatory Intelligence & Drug Approvals1 month agoVertex opens up larger kidney disease opportunity with mid-stage readout
While Vertex is laser-focused on an upcoming FDA decision for povetacicept in immunoglobulin A nephropathy, the APOL1 inhibitor inaxaplin has demonstrated potential “best-in-class” data in a...
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Regulatory Intelligence & Drug Approvals1 month agoFDA Accepts Wearable Sensor-Derived Foot Drop Metrics Under ISTAND as Longitudinal Outcome Measures in Rare Neurological Condition
FDA Accepts Wearable Sensor-Derived Foot Drop Metrics Under ISTAND as Longitudinal Outcome Measures in Rare Neurological Condition
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Regulatory Intelligence & Drug Approvals1 month agoEmpower Clinic Services, LLC dba Empower Pharmacy – 738238 – 09/18/2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
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Regulatory Intelligence & Drug Approvals1 month agoImpact Stories
Stories illustrating how regulatory science impacts the lives and health of people
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Regulatory Intelligence & Drug Approvals1 month agoProteomics-Based Biomarker Discovery: A Systematic Framework to Address Regulatory and Scientific Challenges Across Therapeutic Areas
This research addresses the challenge of integrating novel, data-rich biomarker strategies into drug development.
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Regulatory Intelligence & Drug Approvals1 month agoPar Health recalls IV sedative in US, flagging presence of cellulose, stopper material
Par Health issued a voluntary recall of two lots of the IV sedative dexmedetomidine HCl in 0.9% sodium chloride injection that may be contaminated with cellulose...
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Regulatory Intelligence & Drug Approvals1 month agoPDUFA VIII aims to remove CMC bottlenecks, shore up FDA staffing
BIOCENTURY | POLITICS, POLICY & LAWPDUFA VIII AIMS TO REMOVE CMC BOTTLENECKS, SHORE UP FDA STAFFINGFDA, industry agree on incremental steps to improve reviews, largely symbolic...
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Regulatory Intelligence & Drug Approvals1 month agoPar Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter
ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to...
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Regulatory Intelligence & Drug Approvals1 month agoOtsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection
Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due...
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: What a vote on Grail’s cancer detection test could mean for the company, patients, and regulators
Shares in Grail, the company developing a blood test for cancer, surged Monday after the FDA posted documents ahead of an advisory committee meeting.
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
