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Regulatory Affairs

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Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and...

Admin - September 22, 2023

Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer

Innate Pharma Announces Encore Presentation of Interim Results of Phase 2 TELLOMAK Study With Lacutamab With Updated Olsen 2022 Criteria at the EORTC Cutaneous...

European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata

Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute...

BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After...

Admin - September 19, 2023 0

FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for...

Admin - September 19, 2023 0

CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir)...

Admin - September 19, 2023 0

Rocket Pharmaceuticals Reaches FDA Alignment on Pivotal Phase 2 Trial Design...

Admin - September 13, 2023 0

Alnylam Stock Trading Halted Today; FDA Advisory Committee to Review Supplemental...

Admin - September 13, 2023 0

Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO®...

Admin - September 13, 2023 0

MaaT Pharma Announces European Medicines Agency Granted MaaT033 Orphan Drug Designation...

Admin - September 7, 2023 0

Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization...

Admin - September 6, 2023 0

FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH,...

Admin - September 6, 2023 0

IND for ATA-100, a Gene Therapy for the Treatment of Limb-Girdle...

Admin - September 6, 2023 0

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