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FDA approves first generics of Eliquis americanpharmaceuticalreview
December 24, 2019
The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients ...
FDA Grants Accelerated Approval to enfortumab vedotin-ejfv americanpharmaceuticalreview
December 24, 2019
The Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (PADCEV, Astellas Pharma) for adult patients with locally advanced or ...
FDA Grants Avatrombopag Orphan Drug Designation americanpharmaceuticalreview
December 24, 2019
Dova Pharmaceuticals has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of Chemotherapy-Induced Thrombocytopenia (CIT).
Sunovion Announces FDA Filing Acceptance of Resubmitted NDA for Apomorphine Sublingual Film americanpharmaceuticalreview
December 24, 2019
Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for apomorphine sublingual film (APL-130277) ...
FDA Approves DAYVIGO for Insomnia americanpharmaceuticalreview
December 24, 2019
Eisai announced the U.S. Food and Drug Administration (FDA) approved DAYVIGO™ (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia ...
FDA Approves Schizophrenia Treatment americanpharmaceuticalreview
December 24, 2019
Intra-Cellular Therapies announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults.
CryoLife Receives FDA Authorization to Begin PROACT Xa Clinical Trial americanpharmaceuticalreview
December 24, 2019
CryoLife has received authorization from the U.S. Food and Drug Administration (FDA) pursuant to an Investigational New Drug (IND) application to begin the PROACT Xa clinical trial.
FDA Approves New Treatment for Adults with Migraine americanpharmaceuticalreview
December 24, 2019
The U.S. Food and Drug Administration (FDA) approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura ...
Forward Science Receives FDA Clearance for Orapeutic americanpharmaceuticalreview
December 24, 2019
Forward Science received FDA Clearance for Orapeutic, a non-opioid oral pain relief gel. The company’s flagship product, OralID ...
FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies worldpharmanews
December 23, 2019
The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable ...

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