Monday, January 23, 2023

FDA Approves Iyuzeh (latanoprost ophthalmic solution) for the Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

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In continuation of my update on  Latanoprost Thea Pharma, Inc.  (“Thea”), the U.S. subsidiary of Europe’s leading independent pharmaceutical...
Friday, January 20, 2023

FDA Approves Rezlidhia (olutasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

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Rigel Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA)  approval  of  Rezlidhia (olutasidenib) capsules for the t...
Thursday, January 19, 2023

FDA Approves Krazati (adagrasib) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

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Mirati Therapeutics, Inc.   (NASDAQ: MRTX), a targeted oncology company, announced the U.S. Food and Drug Administration (FDA)  approval of ...
Wednesday, January 18, 2023

FDA Approves Olpruva (sodium phenylbutyrate) for Patients with Urea Cycle Disorders

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In continuation of my update on Phenyl butyrate   Acer Therapeutics Inc. and its collaboration partner, RELIEF THERAPEUTICS Holding SA (“Rel...
Tuesday, January 17, 2023

FDA Approves Sezaby (phenobarbital sodium powder for injection) for the Treatment of Neonatal Seizures

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In continuation of my update on Phenobarbitol  Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd.  announce...
Monday, January 16, 2023

FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations

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In continuation of my update on  albuterol / budesonide Salbutamol ,/ albuterol Budesonide// Pulmicort Airsupra (albuterol/budesonide), form...
Friday, January 13, 2023

FDA Approves Sunlenca (lenacapavir) Twice-Yearly Treatment for People Living With Multi-Drug Resistant HIV

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Gilead Sciences, Inc. (Nasdaq: GILD)  announced that  Sunlenca ®   (lenacapavir), in combination with other antiretroviral(s) (ARV), has bee...
Wednesday, November 16, 2022

FDA Approves Omlonti (omidenepag isopropyl ophthalmic solution) for Reduction of Elevated Intraocular Pressure in Primary Open-Angle Glaucoma or Ocular Hypertension

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Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE)   announced   the U.S. Food and Drug...
Tuesday, November 15, 2022

FDA Approves Iheezo (chloroprocaine hydrochloride ophthalmic gel) for Ocular Surface Anesthesia

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Harrow (Nasdaq: HROW), an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovat...
Monday, November 14, 2022

FDA Approves Relyvrio (sodium phenylbutyrate/taurursodiol) for Patients with Amyotrophic Lateral Sclerosis (ALS)

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In continuation of my update on phenyl butyrate and taurursodiol .. Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”)...
Saturday, November 12, 2022

FDA Approves Lytgobi (futibatinib) for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

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Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved  Lytgo...
Friday, November 11, 2022

FDA Approves Furoscix (furosemide injection) for the At-Home Treatment of Congestion Due to Fluid Overload in Chronic Heart Failure

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scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential t...
Tuesday, October 11, 2022

BioLineRx Announces Submission of New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization

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BioLineRx Ltd.  announced the  submission of  its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Motixafortid...