Thursday, June 16, 2022

FDA Approves Mounjaro (tirzepatide) Injection for the Treatment of Adults with Type 2 Diabetes

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The U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) injection, Eli Lilly and Company's (NYSE: LLY) new once-...
Tuesday, June 14, 2022

FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

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Mitsubishi Tanabe Pharma Corporation (MTPA)   announced the U.S. Food and Drug Administration (FDA)   approval of Radicava ORS (edaravone), ...
Monday, June 13, 2022

Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) FDA Approval

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The Voquezna Triple and Dual Paks offer physicians the flexibility of two different treatment options. The Voquezna Triple Pak contains clar...
Saturday, June 11, 2022

FDA Approves Camzyos (mavacamten) for the Treatment of Symptomatic NYHA Class II-III Obstructive Hypertrophic Cardiomyopathy

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In continuation of my update on mavacamten Bristol Myers Squibb (NYSE: BMY)  announced  the U.S. Food and Drug Administration (FDA) approval...
Friday, June 10, 2022

FDA Approves Vtama (tapinarof) Cream for the Treatment of Plaque Psoriasis in Adults

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Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology,  ...
Thursday, June 2, 2022

FDA Approves Tlando (testosterone undecanoate) for Male Hypogonadism

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Antares Pharma, Inc., (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Admini...
Thursday, May 5, 2022

FDA Approves Xelstrym (dextroamphetamine) Transdermal System for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)

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Noven Pharmaceuticals, Inc., awholly-ownedsubsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that the U.S. Food and Drug Admi...
Wednesday, May 4, 2022

FDA Approves Ztalmy (ganaxolone) for Seizures Associated with CDKL5 Deficiency Disorder

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Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seiz...
Tuesday, May 3, 2022

FDA Approves Igalmi (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

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BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transforma...
Monday, May 2, 2022

FDA Approves Epsolay (benzoyl peroxide) Cream for the Treatment of Rosacea

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Sol-Gel Technologies, Ltd. a dermatology company focused on identifying, developing and commercializing branded and generic topical drug pro...
Monday, April 11, 2022

FDA Approves Vijoice (alpelisib) for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS)

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Novartis  announced  the U.S. Food and Drug Administration (FDA) granting  accelerated approval to  Vijoice ®   (alpelisib) for the treatmen...
Friday, March 11, 2022

FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C)

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                            In continuation of my update on  inclisiran                                      Novartis today announced the US...
Thursday, March 10, 2022

FDA Approves Recorlev (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome

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Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), announce  the U.S. Food and Drug Administration (FDA) approval of Recorlev ®  (levoketoconazo...
Wednesday, March 9, 2022

FDA Approves Quviviq (daridorexant) for the Treatment of Adults with Insomnia

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Idorsia Ltd (SIX: IDIA) announced  the US Food and Drug Administration (FDA)  approval of   Quviviq  (daridorexant) 25 mg and 50 mg for the ...