Friday, December 17, 2021

New Drug Application of Plinabulin (Response Letter from the FDA) for Prevention of Chemotherapy-Induced Neutropenia (CIN)...

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  BeyondSpring Pharmaceuticals  announced the receipt of  a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) ...
Thursday, December 16, 2021

FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery

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  Target Laboratories, Inc.,  announced the U.S. Food and Drug Administration (FDA)  approval of Cytalux for adult patients with ovarian can...
Wednesday, December 15, 2021

FDA Approves Livtencity (maribavir) for Post-Transplant Cytomegalovirus (CMV) Infection/Disease

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Takeda Pharmaceutical Company Limited   (“Takeda”)   announced   the U.S. Food and Drug Administration (FDA)   approval of    Livtencity ™ (...
Tuesday, December 14, 2021

FDA Approves Eprontia (topiramate) Oral Solution for Epilepsy and Preventive Treatment of Migraine

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 In continuation of my update on  topiramate... Azurity Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval...
Monday, December 13, 2021

FDA Approves Scemblix (asciminib) for the Treatment of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)

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  Novartis announced   the US Food and Drug Administration (FDA) approval of Scemblix ®  (asciminib) for the treatment of chronic myeloid le...
Friday, December 10, 2021

FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease...

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  Oyster Point Pharma, Inc. (Nasdaq: OYST),  announced  the U.S. Food and Drug Administration (FDA) approval of    Tyrvaya   (varenicline so...
Thursday, December 9, 2021

FDA Approves Xipere (triamcinolone acetonide injectable suspension) for the Treatment of Macular Edema Associated with Uveitis

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In continuation of my update on  triamcinolone  ....... Biomedical, Inc., a biopharmaceutical company    announced  the U.S. Food and Drug A...
Wednesday, December 8, 2021

FDA Approves Tavneos (avacopan) for the Adjunctive Treatment of ANCA-Associated Vasculitis

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ChemoCentryx, Inc., (Nasdaq: CCXI), announced  the U.S. Food and Drug Administration (FDA)  approval of    Tavneos   (avacopan), an orally a...
Tuesday, December 7, 2021

FDA Approves Livmarli (maralixibat) for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome

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Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM),  announced the U.S. Food and Drug Administration (FDA)   approval of  Livmarli   (maralixibat) o...
Monday, December 6, 2021

FDA Approves Qulipta (atogepant) Oral CGRP Receptor Antagonist for the Preventive Treatment of Migraine

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In continuation of my update on  Qulipta (atogepant),    AbbVie (NYSE: ABBV)    announced  the U.S. Food and Drug Administration (FDA) appro...
Saturday, December 4, 2021

FDA Approves Opzelura (ruxolitinib) Cream for the Treatment of Atopic Dermatitis (AD)

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In continuation of my update on  Opzelura (ruxolitinib)   ,  Incyte (Nasdaq:INCY) announced  the U.S. Food and Drug Administration (FDA)  ap...