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

RADNOR, Pa. -- (BUSINESS WIRE) -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today annou

FDA Approves Opdualag (nivolumab and relatlimab-rmbw) for the Treatment of Patients with Unresectable or Metastatic Melanoma

PRINCETON, N.J.--(BUSINESS WIRE) -- March 18, 2022 -- Bristol Myers Squibb (NYSE: BMY) today announced that Opdualag (nivolumab and relatlimab-rmbw),anew, first-in-class,fixed-dose combination of nivo

FDA Approves Nasonex 24HR Allergy (mometasone furoate) Nasal Spray for OTC Use

DUBLIN, March 17, 2022 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Quality, Affordable Self-Care Products, today announced that it has received final approval from the U.S.

FDA Approves Adlarity (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease

BOSTON, March 14, 2022 /PRNewswire/ -- Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announc

FDA Approves Carvykti (ciltacabtagene autoleucel) BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

HORSHAM, Pa., February 28, 2022 -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved Carvykti (ciltacabtagene autol

FDA Approves Vonjo (pacritinib) for the Treatment of Adult Patients with Myelofibrosis and Thrombocytopenia

SEATTLE, Feb. 28, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced the U.S. Food and Drug Administration (FDA) has approved Vonjo (pacritinib) for the treatment of adults with i

FDA Approves Releuko (filgrastim-ayow), a Biosimilar to Neupogen

February 28, 2022 -- The United States (U.S.) Food and Drug Administration (FDA) has approved Releuko (filgrastim-ayow), a biosimilar to Neupogen (filgrastim). The FDA approval was based on a review o

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

February 28, 2022 -- The U.S. Food and Drug Administration has approved Norliqva (amlodipine) oral solution for the treatment of: Hypertension in adults and children 6 years and older, to lower blood

FDA Approves NephroScan (Kit for the Preparation of Technetium Tc 99m Succimer Injection) for Radiodiagnostic Imaging

LONDON, UK, 21 February 2022 -- Theragnostics announces that NephroScan, its radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patien

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

CAMBRIDGE, Mass., Feb. 17, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, toda

FDA Approves Enjaymo (sutimlimab-jome) for Use in Patients with Cold Agglutinin Disease

Paris, February 4, 2022. -- The U.S. Food and Drug Administration (FDA) has approved Enjaymo™ (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold

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

WOBURN, MA, February 7, 2022 -- Azurity Pharmaceuticals, Inc., a private specialty pharmaceutical company, focused on developing innovative products to meet the unique needs of patients with underserv