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

Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is characterized by

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

NEW HAVEN, Conn., April 06, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop tr

FDA Approves Tlando (testosterone undecanoate) for Male Hypogonadism

EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc., (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration gra

FDA Approves Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Targeted Radioligand Therapy for Treatment of Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

FDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions2 Metastatic prostate cancer has a 5-year surviva

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

Miami, FL and Jersey City, NJ -- March 23, 2022 -- Noven Pharmaceuticals, Inc., awholly-ownedsubsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that the U.S. Food and Drug Administratio

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