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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
Merck’s KEYNOTE-522 Success; BMS Licenses PRX019, Prothena Gets $80M
2024-06-19
Pie Medical Imaging announces enrollment completion of the FASTIII clinical trial
2024-06-18
Company Presentations at BIO 2024 Inspire Partnering
2024-06-14
GV Regains Compliance with Nasdaq Minimum Bid Price Requirement
2024-06-13
ARPA-H Fast-Tracks Biotech Startups: Funding Insights from BIO 2024 Panel
2024-06-12
Gene Therapy Innovations and Financial Challenges for the Future of Medicine
2024-06-12
BIO Releases DEI Survey in Partnership with Korn Ferry
2024-06-11
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