FDA News

Protalix and Chiesi Submit BLA to the FDA for Pegunigalsidase Alfa for the Treatment of Fabry Disease

CARMIEL, Israel, May 28, 2020 /PRNewswire/ —  Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, or the Company, together with its development and commercialization partner Chiesi …

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FDA Approves Astellas’ VESIcare LS, the First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

NORTHBROOK, Ill., May 27, 2020 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has approved VESIcare LS™ (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 …

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FDA Grants Rare Pediatric Disease Designation to Azitra’s ATR-12 for Treatment of Netherton Syndrome

BRANFORD, Conn.–(BUSINESS WIRE)–Azitra, Inc., a clinical-stage medical dermatology company addressing serious skin conditions by harnessing the microbiome, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to ATR-12 for the treatment of Netherton syndrome (NS), a chronic genetic skin disease that can be life …

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FDA Approves Amivas’ Artesunate for Injection for Treatment of Patients with Severe Malaria

FREDERICK, Md., May 27, 2020 /PRNewswire/ — Artesunate for Injection 110 mg, powder and solvent for solution is approved by FDA for initial treatment of severe malaria in adult and pediatric patients. Artesunate for Injection is in a group of drugs known as “artemisinin derivatives” and is on the World …

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FDA Approves Opdivo + Yervoy Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent NSCLC

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer …

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FDA Approves Dupixent as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

PARIS and TARRYTOWN, N.Y. – May 26, 2020 – The U.S. Food and Drug Administration (FDA)  approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic …

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Cellectar Receives FDA Fast Track Designation for CLR 131 in Lymphoplasmacytic Lymphoma/Waldenstrom’s Macroglobulinemia

FLORHAM PARK, N.J., May 26, 2020 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CLR 131 in …

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FDA Grants Priority Review to Alnylam’s Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – in development for the …

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Aurinia Completes Rolling Submission of Voclosporin NDA to the FDA for Treatment of Lupus Nephritis

VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the completion of the rolling submission of a New Drug Application (“NDA”) to the United States Food and Drug Administration …

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FDA Approves Takeda’s Alunbrig as a First-Line Treatment for Patients Diagnosed with Rare and Serious Form of Lung Cancer

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the …

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