Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Friday, August 21, 2026

FDA Accepts New Drug Application for Zipalertinib for the Treatment of Non-Small Cell Lung Cancer

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Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc.(Nasdaq: CGEM) announced  the U.S. Food and Drug Admini...
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...
Monday, July 20, 2026

Egetis Announces FDA Acceptance and Priority Review of NDA for Emcitate (tiratricol) for MCT8 Deficiency

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Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX), today announced that the U.S. Food and Drug Administrati...
Monday, July 13, 2026

FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis

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Acrotech Biopharma Inc., a bio-pharmaceutical company focused on developing and commercializing innovative propriety medications, in collabo...
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...
Thursday, July 9, 2026

FDA Approves Desmoda (desmopressin acetate) Oral Solution for Central Diabetes Insipidus

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In continuation of my update on  Desmoda Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical co...
Wednesday, July 8, 2026

FDA Grants Accelerated Approval to Yuviwel (navepegritide) for Children with Achondroplasia

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Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s A...
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, 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 13, 2026

Eylea HD (aflibercept) Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications

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Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food and Drug Administration (FDA) approval of Eylea HD (aflibercept) Inje...
Tuesday, February 3, 2026

FDA Issues Complete Response Letter for Biohaven's Vyglxia (troriluzole) New Drug Application for Spinocerebellar Ataxia

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Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development a...
Wednesday, August 13, 2025

FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

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In continuation of my update on  lisdexamfetamine Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Arynta™ (lisd...
Tuesday, August 12, 2025

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

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In continuation of my update on  nitisinone Cycle Pharmaceuticals has announced   the FDA approval of  Harliku (nitisinone) Tablets for the ...
Monday, August 11, 2025

FDA Grants Accelerated Approval to Zegfrovy (sunvozertinib) for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseas...
Friday, July 25, 2025

FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ibtrozi (taletrectinib) for the treatment of adult pat...