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FDA Commissioner Scott Gottlieb Statement on Agency’s Efforts to Advance Development of Gene Therapies

Once just a theory, gene therapies are now a therapeutic reality for some patients. These platforms may have the potential to treat and cure some of our most intractable and vexing diseases. The policy framework we construct for how these products should be developed, reviewed by regulators, and reimbursed, will …

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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Receives FDA Approval for Certain Patients with Metastatic Colorectal Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda for Treatment of Advanced Hepatocellular Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated …

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FDA Grants Eagle Seven Year Orphan Drug Exclusivity for Bendeka

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute …

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FDA Approves Xeomin for Adult Patients with Sialorrhea

fda RALEIGH, N.C.–(BUSINESS WIRE)–Merz North America announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XEOMIN® (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. XEOMIN is the first and only neurotoxin with this approved indication in …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda and Chemo as First-Line Treatment for Metastatic Squamous NSCLC

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic …

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FDA Lifts Clinical Hold on APTO-253, Aptose’s Investigational Drug for Hematological Cancers

SAN DIEGO and TORONTO, June 29, 2018 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has lifted the clinical hold on APTO-253, Aptose’s investigational drug for hematologic cancers. APTO-253 is the only known clinical-stage …

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FDA Approves Array BioPharma’s Baftovi in Combination with Mektovi for Treatment of Metastatic Melanoma

BOULDER, Colo., June 27, 2018 /PRNewswire/ — Array BioPharma Inc. (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI™ capsules in combination with MEKTOVI® tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma. …

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FDA Grants Priority Review to Pfizer’s Glasdegib for Treatment of Patients with Previously Untreated Acute Myeloid Leukemia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in …

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FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Waldenström’s Macroglobulinemia

NORTH CHICAGO, Ill., June 25, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab (RITUXAN®) as a new treatment option for Waldenström’s macroglobulinemia (WM), a …

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