Showing posts with label for. Show all posts
Showing posts with label for. Show all posts
Thursday, July 16, 2026

FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

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Sentynl Therapeutics Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), an...
Wednesday, July 15, 2026

FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease

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Sentynl Therapeutics Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), an...
Saturday, July 11, 2026

FDA Approves Bysanti (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia

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Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti (milsaperido...
Tuesday, July 7, 2026

FDA Approves Icotyde (icotrokinra) for the Treatment of Plaque Psoriasis

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Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Icotyde (icotrokinra), an in...
Monday, July 6, 2026

FDA Approves Lynavoy (linerixibat) for Cholestatic Pruritus in Patients with Primary Biliary Cholangitis

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GSK  announced   the US Food and Drug Administration (FDA)  approval of  Lynavoy (linerixibat) for the treatment of cholestatic pruritus in ...
Tuesday, June 30, 2026

Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs

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Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmace...
Monday, June 29, 2026

Elevar Therapeutics Announces FDA Acceptance for Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma Treatment

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Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevat...
Saturday, June 6, 2026

U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma

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Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) ...
Friday, May 29, 2026

FDA Approves Rhapsido (remibrutinib) for the Treatment of Chronic Spontaneous Urticaria

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Novartis announced today that Rhapsido (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult...
Thursday, May 21, 2026

FDA Approves Lasix ONYU (furosemide) for Treatment of Edema in Heart Failure

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SQ Innovation, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its drug-device combination Lasix ONYU (fu...
Thursday, May 7, 2026

Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease

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Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra)  announced   the U.S. Food and Drug Administration (FDA)   acceptance the  review of the...
Friday, May 17, 2019

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression

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U.S. Food and Drug Administration   approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum dep...
Wednesday, April 24, 2019

FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension

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In continuation of my update on   latanoprost   Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic phar...