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Administration

Delegation from U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and Local Government Officials Visit Amneal Manufacturing Site in India

Delegation from U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and Local Government Officials Visit Amneal Manufacturing Site in India

その他ヘルスヘルスケア製薬　 TimeLine: Administration Delegation from Food and Drug

2023年08月30日

Otsuka Medical Devices and Recor Medical Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension

Otsuka Medical Devices and Recor Medical Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension

ヘルスケア医療機器心臓学臨床試験　 TimeLine: Administration FDA Food and Drug

2023年08月23日

Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Alzheimer’s Dementia

Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Alzheimer’s Dementia

バイオテクノロジーヘルスケアメンタルヘルス臨床試験製薬　 TimeLine: Administration Advisory Committee Meeting on REXULTI brexpiprazole FDA

2023年04月17日

Otsuka Medical Devices and ReCor Medical Announce Submission of Application for Pre-Market Approval of the Paradise™ Ultrasound Renal Denervation (uRDN) System to the U.S. Food and Drug Administration

Otsuka Medical Devices and ReCor Medical Announce Submission of Application for Pre-Market Approval of the Paradise™ Ultrasound Renal Denervation (uRDN) System to the U.S. Food and Drug Administration

ヘルスケア医療機器臨床試験　 TimeLine: Administration Food and Drug Ultrasound Renal Denervation uRDN

2022年11月30日

Takeda’s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.S. Food and Drug Administration

Takeda’s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.S. Food and Drug Administration

バイオテクノロジーヘルスケアヘルス一般感染症製薬　 TimeLine: Administration BLA Granted Priority Review TAK-003 Takeda’s Biologics License Application

2022年11月23日

CANbridge Pharmaceuticals CAN108 New Drug Application/Orphan Drug Registration (NDA/ORD) for Alagille Syndrome Accepted by the Taiwan Food and Drug Administration

CANbridge Pharmaceuticals CAN108 New Drug Application/Orphan Drug Registration (NDA/ORD) for Alagille Syndrome Accepted by the Taiwan Food and Drug Administration

バイオテクノロジーヘルスケアヘルス一般腫瘍学臨床試験製薬　 TimeLine: Administration Application NDA ORD Registration

2022年03月29日

Dr. Reddy’s Laboratories Announces Approval for Lenalidomide Capsules from the U.S. Food and Drug Administration (USFDA)

Dr. Reddy’s Laboratories Announces Approval for Lenalidomide Capsules from the U.S. Food and Drug Administration (USFDA)

バイオテクノロジーヘルスケア製薬　 TimeLine: Administration Food and Drug Reddy's Laboratories Announces Approval for Lenalidomide Capsules USFDA

2021年10月19日

SCC Soft Computer’s Blood Bank Product Receives 510(k) Clearance from the U.S. Food and Drug Administration

その他ヘルスヘルスケアヘルス一般医療用品医療管理　 TimeLine: Administration Food and Drug SCC Soft Computer’s Blood Bank Product Receives

2021年01月20日

Astex Pharmaceuticals Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML

Astex Pharmaceuticals Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML

ヘルスケア腫瘍学臨床試験製薬　 TimeLine: Administration Astex Pharmaceuticals Announces ASTX727 or oral C-DEC FDA Food and Drug

2020年02月12日