Showing posts with label for. Show all posts
Showing posts with label for. Show all posts
Saturday, October 31, 2026

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

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In continuation of my update on  cefepime cefepime Zidebactam FDA approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic...
Thursday, October 22, 2026

Acetaminophen reaffirmed as first-line medication for treating pain and fever during pregnancy

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In continuation of my update on acetaminophen  Acetaminophen remains the recommended first-line medication to treat pain and fever during p...
Monday, October 19, 2026

With trial success, Gilead paves way for broader use of Livdelzi

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A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug's ability to normalize a key marker of disease progr...
Wednesday, October 14, 2026

China approves fruquintinib combination for kidney cancer

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China’s National Medical Products Administration (NMPA) has approved a combination of ELUNATE (fruquintinib) and TYVYT (sintilimab) for pati...
Monday, October 12, 2026

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

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Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company,   announced   the U.S. Food and Drug Administration   approval of  Trimbow...
Tuesday, October 6, 2026

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug | FDA

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Today, the U.S. Food and Drug Administration is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the s...
Saturday, September 26, 2026

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

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In continuation of my update on beclomethasone ,  Formoterol   &  Glycopyrrolate Formoterol   beclomethasone ,  Glycopyrrolate Chiesi US...
Thursday, August 13, 2026

Xspray Pharma Re-Submits its FDA Application for Dasynoc

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Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc® to the U.S. Food and Drug Administration (FDA). Da...
Monday, August 10, 2026

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara) Brain Cancer Imaging Candidate

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Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) announced the resubmission of a New Drug Application (NDA) to the United Stat...
Wednesday, August 5, 2026

Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-Positive NSCLC

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Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically pr...
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...