NDA News-CliniExpert

FDA Approves Vivjoa (oteseconazole) for the Treatment of Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection)

DURHAM, N.C.--(BUSINESS WIRE) -- The U.S. Food and Drug Administration (FDA) approved Vivjoa (oteseconazole capsules), an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal c

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

NESS ZIONA, Israel and ZUG, Switzerland, April 25, 2022 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing bran

FDA Approves Alymsys (bevacizumab-maly), a Biosimilar to Avastin

BRIDGEWATER, N.J.--(BUSINESS WIRE) April 13, 2022 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved

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