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FDA Approves Mylan’s Wixela Inhub, First Generic of Advair Diskus, for Certain Patients with Asthma or COPD

HERTFORDSHIRE, England and PITTSBURGH, Jan. 31, 2019 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) today announced the U.S. Food and Drug Administration (FDA) approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of ADVAIR DISKUS®. Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA …

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FDA Expands Lilly’s Alimta Label with Combination of Keytruda and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous NSCLC

INDIANAPOLIS, Jan. 31, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with KEYTRUDA® (pembrolizumab), developed and marketed by Merck (known as MSD outside the U.S. and Canada), and platinum chemotherapy for the first-line treatment …

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REGENXBIO Receives Rare Pediatric Disease Designation for RGX-181 Gene Therapy for Treatment of CLN2 Form of Batten Disease

ROCKVILLE, Md., Jan. 31, 2019 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the U.S. Food and Drug Administration(FDA) granted Rare Pediatric Disease Designation to RGX-181. RGX-181 is a one-time treatment candidate for …

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FDA Grants Orphan Drug Designation to Prana’s PBT434 for Treatment of Multiple System Atrophy

MELBOURNE, Australia & SAN FRANCISCO–(BUSINESS WIRE)–Prana Biotechnology Ltd (ASX: PBT, NASDAQ: PRAN) (“Prana” or “the Company”) has today announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its lead molecule, PBT434, for the treatment of Multiple System Atrophy (MSA). This is the first time the …

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Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people …

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Merck Receives Breakthrough Therapy Designation from FDA for V114, Investigational 15-Valent Conjugate Vaccine for Prevention of Invasive Pneumococcal Disease

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the …

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FDA Grants Breakthrough Device Designation to C2N Diagnostics’ Blood Test to Screen for Alzheimer’s Disease Risk

ST. LOUIS–(BUSINESS WIRE)–C2N Diagnostics today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for C2N’s proprietary brain amyloidosis blood test. This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis. To qualify for …

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FDA Grants Fast Track Designation to Innate Pharma’s IPH4102 for Treatment of Relapsed or Refractory Sézary Syndrome

Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. …

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FDA Approves Imbruvica Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Jan. 28, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest FDA approval …

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FDA Places Partial Clinical Hold on Advaxis’ Phase 3 Cervical Cancer Study

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company’s ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced …

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