US Congress probes big pharma’s China trials, pushes FDA data banFDA Issues CRL for Oxylanthanum Carbonate in Hyperphosphatemia for CKD Patients on DialysisFDA Grants Reduced Risk Status to 20 ZYN Nicotine PouchesVertex (VRTX) Just Won FDA Approval To Treat 5,500 More Young ChildrenFDA Accepts Sandoz Applications for Generic Tirzepatide
Dr Reddy’s Says US FDA Issued Seven Observations To Bachupally PlantUS FDA updates guidance to speed up drug developmentAurobindo Pharma Receives 2 US FDA Observations Following Inspection At Hyderabad FacilityWhy India’s first US FDA-approved antibiotic can change the fight against superbugsUS FDA officials say hiring picks up speed with more than 2,000 jobs to start
US FDA sends 25 letters to telehealth companies over claims on compounded weight-loss drugsUS FDA approves GSK’s oral antibiotic for drug-resistant UTIsFDA Approves First Oral Carbapenem Antibiotic for Complicated UTIsUS, UK healthcare agencies partner to strengthen regulatory collaborationTwo decades of growth and trends in the FDA authorization of digital medical devices
FDA clears new computer-assisted device for removing clots in stroke patientsUS FDA approves Pfizer’s bleeding disorder drug for childrenFDA Clears IND for Phase 3 Study of Cardiovascular Diagnostic ProgramUS FDA Issues Import Alert Against Dabur’s Plant over Data Integrity LapsesFDA updates draft biosimilar guidance, signalling greater flexibility for developers
FDA Draft Guidance Could Streamline Rare Disease Gene Therapy DevelopmentLupin and Natco Receive Approval from U.S. FDA for Eribulin Mesylate Injection” Philips receives FDA 510(k) clearance for Elevate Plus for EPIQ Elite and Affiniti, delivering AI advancements in general imaging ultrasound”US FDA to review AI-based tool to predict drug-related liver damageFDA approves third interchangeable insulin glargine biosimilar Langlara
Partners
Supporting development and regulatory strategy for biosimilars and complex biologic products.
Advising on regulatory pathways for complex formulations and value-added generic products.
Helping global innovators navigate FDA pathways and prepare for successful U.S. market entry.
Collaborating with manufacturers and CMOs to ensure compliance, quality, and regulatory alignment.
Partnering with emerging companies to build a strong regulatory and commercial foundation.