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 ...
Tuesday, March 8, 2022

FDA Approves Ryaltris (mometasone and olopatadine) Nasal Spray for Seasonal Allergic Rhinitis

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In continuation of my update on  olopatadine Glenmark Pharmaceuticals Limited, announced the  FDA approval of its New Drug Application (NDA)...
Monday, March 7, 2022

FDA Approves Cibinqo (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

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Pfizer Inc. (NYSE: PFE) announced  the United States (U.S.) Food and Drug Administration (FDA) approval of   Cibinqo  (abrocitinib), an oral...
Friday, March 4, 2022

FDA Approves Fleqsuvy (baclofen oral suspension) for the Treatment of Spasticity

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Azurity Pharmaceuticals, Inc., a private specialty pharmaceutical company, focused on developing innovative products to meet the unique need...
Thursday, March 3, 2022

FDA Approves Pyrukynd (mitapivat) as First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency

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Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseas...
Wednesday, March 2, 2022

FDA Approves Norliqva (amlodipine) Oral Solution for Hypertension and Coronary Artery Disease

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In continuation of my update on  amlodipine besylate The U.S. Food and Drug Administration has approved Norliqva (amlodipine) oral solution ...
Thursday, January 27, 2022

Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib

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Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, announced the submission of  its New...
Wednesday, January 26, 2022

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

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Novartis  announced the US Food and Drug Administration (FDA) approval of Leqvio ®  (inclisiran), the first and only small interfering RNA (...
Monday, January 24, 2022

FDA Approves Apretude

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  ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Lim...
Friday, January 7, 2022

New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

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    Spero Therapeutics, Inc. announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeki...
Thursday, January 6, 2022

Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib for metastatic NSCLC with HER2 exon 20 insertion mutations.

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                     Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies,  announced tha...
Wednesday, January 5, 2022

Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome

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  Stealth BioTherapeutics Corp, announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Adminstration (FDA) for e...