Friday, February 14, 2020

FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults

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Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous...
Thursday, February 13, 2020

FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine

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In continuation of my update on  Ubrelvy (ubrogepant) Allergan plc (NYSE: AGN),  announced that the U.S. Food and Drug Adminis...
Wednesday, February 12, 2020

Overdose, Relapse After Buprenorphine Discontinuation High

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In continuation of my update on  buprenorphine Buprenorphine treatment may be needed for several years after an opioid overdose ...
Tuesday, February 11, 2020

Exeltis USA, Inc. Announces the Approval of Slynd (drospirenone), the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window

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Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administra...
Friday, February 7, 2020

New Antibiotic Xenleta Approved for Community-Acquired Bacterial Pneumonia

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Xenleta (lefamulin) has been approved to treat adults with community-acquired bacterial pneumonia, the U.S. Food and Drug Administ...
Wednesday, February 5, 2020

FDA Accepts Correvio's Resubmitted New Drug Application for Brinavess (vernakalant)

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In continuation of my update on vernakalant  Correvio Pharma Corp. (CORV) (CORV), a specialty pharmaceutical company focused on comm...
Tuesday, February 4, 2020

Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma

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Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U...
Friday, January 31, 2020

Sunovion Announces Acceptance by the U.S. FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder

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In continuation of my update on dasotraline, Sunovion Pharmaceuticals Inc.(Sunovion) today announced that the U.S. Food and Drug Admin...
Thursday, January 30, 2020

Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

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Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases ...
Wednesday, January 29, 2020

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105

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In continuation of my update on    lamotrigine Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused ...
Tuesday, January 28, 2020

AbbVie's HIV Drug Aluvia (Lopinavir/ritonavir) Seen as Potential Treatment for Coronavirus

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In continuation of my update on Lopinavir/Fritonavior   More than 80 people have died from the coronavirus in China. The Chinese gov...
Saturday, January 25, 2020

FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis

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Celgene Corporation (NASDAQ: CELG)  announced the U.S. Food and Drug Administration (FDA) approval of  Inrebic (fedratinib) for the ...
Friday, January 24, 2020

FDA Approves Eylea (aflibercept) Injection Prefilled Syringe

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Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)  announced the U.S. Food and Drug Administration (FDA)   approval the Chemistry, Manufactur...
Thursday, January 23, 2020

FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis

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In continuation of my update on   Rinvoq (upadacitinib) AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company...