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Complete Response Letter
Ascendis’ Hormone Drug Hits Another FDA Roadblock on Path to Approval
2023-05-02
FDA Rejects Sesen Bio’s Bladder Cancer Drug Application, Asks Additional Data
2021-08-16
FDA Rejection of Type 1 Diabetes Drug Impacts Provention Bio’s Stocks
2021-07-07
FDA Rejects Protalix’s Enzyme Replacement Therapy for Rare Genetic Disease
2021-04-29
Acadia Fumes Over FDA Rejection of its Psychosis Drug Nuplazid
2021-04-06
FDA Rejects Athenex’s Breast Cancer Treatment, Recommends Another Clinical Trial
2021-03-03
FDA Requests Additional Info for Liquidia’s Pulmonary Arterial Hypertension Treatment
2020-11-27
FDA Rejects BioMarin Pharmaceuticals’ Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A
2020-08-20
With NASH Drug Rejected, Intercept CEO Lambasts FDA’s Evolving Guidelines
2020-07-01
Expedited Approval of Vitrakvi® Marks Many Firsts in Cancer Therapy
2018-12-04
LATEST
The Latest Talk in Cancer Immunotherapy: A Brief Overview of Developments & Current Players in the Exosome Space
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Unlocking the Gut Code: Japan’s Pharmaceutical Sector Explores the Future of Microbiome Therapeutics
2025-04-23
Advancing Pharmaceutical Regulatory Cooperation in Asia: The Vision and Challenges of GMP Inspection Reliance
2025-04-23
The Digital Revolution of Drug Labelling: FHIR and the Global Blueprint for e-Labelling
2025-04-23
Cross-Border Trust and Transparency: The New Landscape of Bridging the Regulatory Review in the Asia-Pacific
2025-04-23
From Cancer to Cosmetics, Physiological to Pathological – The Field of Exosomes Full of Endless Opportunities
2025-04-22
Sumitomo Pharma’s Comeback Story: Reinventing a Century-Old Giant in a Post-Patent Era
2025-04-22
EVENT
2025-04-21
World Vaccine Congress Washington 2025
Washington, U.S.A
2025-04-25
AACR Annual Meeting 2025
Chicago, U.S.A
2025-04-26
SABPA OC/LA 17th Annual Biomedical Forum
Irvine, California, United States
2025-05-03
29th Taiwan Joint Cancer Conference 2025
Taipei, Taiwan
2025-05-05
Swiss Biotech Day 2025
Basel, Switzerland
2025-05-13
ASGCT 28th Annual Meeting 2025
New Orleans, U.S.A.
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