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Maroc Maroc - MANGALOREMIRROR.COM - A la Une - 02/Jul 12:37

Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis

– Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 – – EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA) BOSTON–(BUSINESS WIRE)– “The FDA acceptance of our vanza triple application and the MAA validation by the EMA represent important milestones …

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Vertex (VRTX) NDA for Vanza Triple Therapy Accepted by FDA

zacks.com - 03/Jul 13:13

The FDA accepts Vertex's (VRTX) new drug application for vanza triple therapy for people living with cystic fibrosis aged six years and above. A...

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EMA initiates review of Roche's Elevidys MAA for treatment of Duchenne muscular dystrophy

pharmabiz.com - 25/Jun 00:00

Roche announced that the European Medicines Agency (EMA) has validated and initiated review of the marketing authorisation application (MAA) for...

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GSK's Filing for Expanded Use of Jemperli Gets EMA Acceptance

zacks.com - 24/Jun 13:39

The European Medicines Agency accepts GSK's application for the expanded use of Jemperli plus chemotherapy to include all adult patients with primary...

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Synaptogenix gets US FDA authorization of IND application for clinical trial for Bryostatin─1 to treat multiple sclerosis

pharmabiz.com - 01/Jul 00:00

Synaptogenix, Inc., an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, announced that the Food & Drug...

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SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

drugs.com - 01/Jul 06:07

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused...

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Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

drugs.com - 26/Jun 04:06

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

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SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

zacks.com - 02/Jul 16:12

SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with...

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SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

zacks.com - 02/Jul 16:12

SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with...

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Unilab lauds FDA’s proactive measures vs fake drugs

philstar.com - 24/Jun 04:00

Pharmaceutical and healthcare company Unilab Inc. lauded the Food and Drug Administration (FDA) for taking proactive measures to protect the public...

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Altria's (MO) Smoke-Free Growth Underway With Latest FDA Nod

zacks.com - 24/Jun 14:20

Altria's (MO) NJOY obtains authorization from the U.S. Food and Drug Administration for menthol e-vapor products.

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