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Regulatory India
Sun Pharma Temporarily Pauses Shipments from Mohali Following FDA’s Mandate for Corrective Actions
2023-04-24
Trials & Approvals FDA Approval
First Treatment Targeting ALS Genetic Cause Could be a Reality with FDA Approval
2022-07-27
Licensing Anemia
Akebia Therapeutics Gains $55M Following Deal Termination by Otsuka Pharmaceutical
2022-07-04
Trials & Approvals ALS
Amylyx’s New ALS Drug Review Impeded as FDA Members Disagreed with Clinical Trial Results
2022-04-04
Feature FDA
FDA Announces Draft Guidances on Genome Editing and CAR T Cell Therapy
2022-03-25
Trials & Approvals COVID-19
Remdesivir Cleared for Treating Non-Hospitalized COVID-19 Patients
2022-01-24
Trials & Approvals Acute Myeloid Leukemia
FDA Places Clinical Hold on Kura Oncology’s Acute Myeloid Leukemia Therapeutic
2021-11-25
Trials & Approvals Organ Transplant
Takeda’s Livtencity Bags FDA Approval for the Treatment of Post-Transplant Infection
2021-11-24
Trials & Approvals Cancer
FDA Approves Aadi Bioscience’s First Product to Treat Rare Cancer
2021-11-23
Trials & Approvals Gene Therapy
FDA Grants Priority Review for bluebird bio’s β-Thalassemia Gene Therapy
2021-11-23
Trials & Approvals Blood Cancer
FDA Approves First Interferon Therapy for Rare Blood Cancer
2021-11-15
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Kexing Biopharm Facility Passes EU GMP Certification for Paclitaxel for Injection (Albumin Bound)
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