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Regulatory Affairs

Medical Device Registration in Japan-Todokede, Ninsho and Shonin Pathways

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Amgen Completes Acquisition Of Otezla® (apremilast) for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis

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Aquestive Therapeutics’ treatment approved by FDA for neurological disorder amyotrophic lateral sclerosis (ALS)

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AbbVie to present Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) , in American Society of Hematology (ASH) Annual Meeting for the treatment of...

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Harpoon Therapeutics and AbbVie Announce an elite worldwide option and license transaction for HPN217 and Expand Existing Discovery Collaboration

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XCOPRI (cenobamate tablets) approved by FDA for the treatment partial-onset seizures in adults

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US Food and Drug Administration (FDA) approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

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U.S. FDA approved IN.PACT AV paclitaxel-coated balloon for the treatment of Arteriovenous Fistula Lesions

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Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

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Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the...

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Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

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NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

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