Category:

Regulatory

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Business and Market Strategy

Regulatory

Lupin Receives U.S. FDA Approval for Interchangeable Ranibizumab Biosimilar Ranluspec

Regulatory

FDA Launches One-Day Inspection Pilot to Enhance Risk-Based Oversight

Regulatory

FDA Novel Drug Approvals 2026 Q1: Full List & Insights

book/virender-singh-molecules-mentors-mindsets/

Regulatory

FDA Grants Full Approval to Tecartus CAR-T Therapy for Mantle Cell Lymphoma

Regulatory

FDA Approves drug for Neurologic Symptoms of Hunter Syndrome

Regulatory

FDA Approves Kresladi: First Gene Therapy for Rare Immune Disorder LAD-I

Regulatory

CDSCO Flags 4 Spurious Drugs and 194 Substandard Medicines in February 2026

Regulatory

Immunogenicity Risk Assessment Drives Smarter and Safer Drug Development | EpiVax

Regulatory

FDA Draft Guidance on NAMs Shifts Focus to Validation in Drug Development

Regulatory

FDA Novel Drug Therapy Approvals for 2025 | Quarter 4

Regulatory

FDA Approves New Gene Therapy for Spinal Muscular Atrophy (SMA)

Regulatory

Accord BioPharma Announces FDA Approval of Denosumab Biosimilars

book/virender-singh-molecules-mentors-mindsets/

How AI is Transforming Oral Cancer Screening in India: The Story of Mukhia+

June 30, 2026

Protoporphyrin IX regulates the phase separation behavior of α-Synuclein

June 29, 2026

Targeting a Bacterial Master Regulator to Combat Drug-Resistant Pneumonia

June 27, 2026

Biopharmaceuticals to Shape Future of Healthcare, India Aims to Launch 100 Biologics by 2047

June 26, 2026

Health Ministry Expands QR Code-Based Drug Traceability to Vaccines, Antimicrobials and Cancer Medicines

June 26, 2026