FDA News

FDA Approves Lilly’s Tauvid for Injection for Use in Patients Being Evaluated for Alzheimer’s Disease

INDIANAPOLIS, May 28, 2020 /PRNewswire/ — TAUVID™, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).1 A neuropathological …

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Cardiff Oncology Announces FDA Grants Fast Track Designation to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer

SAN DIEGO, May 28, 2020 /PRNewswire/ — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and leukemia, today announced that the U.S. Food and Drug Administration (FDA) …

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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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