CLINSQUARE: CLINICAL RESEARCH COURSES
Monday, February 24, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW

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AVITA medical receives U.S. FDA investigational device exemption approval of clinical feasibility study in order to evaluate Recell system for Vitiligo

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The Drug approval process in EU:

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Big Change in FDA process for Biologics:

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U.S. Food and Drug Administration (FDA) approved sNDA to Revise Flexion Therapeutic’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA)...

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Biologics Approval Pathways in the USA:

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Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:

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U.S. Food and Drug Administration (FDA) approved Allergan’s UBRELVY(ubrogepant) for the acute treatment of migraine with or without aura in adults.

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U.S. FDA approves EISAI’S DAYVIGO™ (LEMBOREXANT) for treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults

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Roche and Sarepta Therapeutics enters licensing agreement in order to improve the lives of patients living with Duchenne muscular dystrophy

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FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for the treatment of anemia of chronic kidney disease (CKD)

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U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s Novel Antipsychotic CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults

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Zosano Announces FDA Submission of 505(b)(2) New Drug Application for Qtrypta for the acute treatment of migraine

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