Tuesday, August 20, 2019

FDA Approves Wakix (pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy

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Harmony Biosciences, LLC (Harmony) announced the U.S. Food and Drug Administration (FDA) approval of Wakix (pitolisant) for the treatm...
Thursday, August 15, 2019

FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)

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In continuation of my update on tofacitinib  The U.S. Food and Drug Administration has approved new warnings about an increased risk o...

FDA Approves Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections

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   Imipenem  ( Primaxin)                      Cilastatin                                      Relebactam Merck (NYSE:MRK), known a...
Saturday, July 6, 2019

Statin Use Associated With Higher Incidence of Diabetes

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In continuation of my update on statins There may be a dose-dependent relationship between statin therapy and new-onset diabetes across...
Wednesday, July 3, 2019

FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients

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The U.S. Food and Drug Administration today approved Mavyret (telaprevir and pibrentasvir) tablets to treat all six genotypes of hepatit...
Tuesday, July 2, 2019

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

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In continuation of my update on  dapagliflozin , and metformin hydrochloride   Dapagliflozin               Saxagliptin    ...
Sunday, June 30, 2019

FDA Approves Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis In Adults

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In continuation of my update on    tazarotene   Ulobetasol                                                                        ...
Saturday, June 29, 2019

Agios Announces FDA Approval of Tibsovo as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy

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Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism to treat cancer and rare genetic diseases,  announced th...
Friday, June 28, 2019

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome

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In continuation of my update on  amifampridine The U.S. Food and Drug Administration approved Ruzurgi (amifampridine) tablets for ...
Thursday, June 27, 2019

FDA Approves Bavencio (avelumab) Plus Inlyta (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma

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In continuation of my update on axitinib Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business a...