Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Generic FDA Rapid Response Surveys" has been approved by the Office of Management and Budg
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it wil
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. FDA had designated Ryanodex as an Orphan Drug in August 2013. We are very pleased with today s approva
WASHINGTON The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat three types of blood cancer. The FDA has approved three other drugs for the disease in the last year: Roche's Gazyva, Janssen Pharmaceutical's Imbruvica and GlaxoSmithKline's Arzerra. The FDA approved Zydelig for leukemia based
By a News Reporter-Staff News Editor at Vaccine Weekly Protein Sciences Corporation announced that the FDA has approved the Company's strain change amendment for its seasonal influenza vaccine, Flublok. She added, "We are still accepting orders for the fall and providers are encouraged to order through our distributors FFF Enterprises and ASD Hea
The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process. "Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved Zydelig 150 mg tablets for the treatment of three B-cell blood cancers. Zydelig is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia for whom rituximab alone would be considered appropriate therapy and as...
U.S. Food and Drug Administration has sanctioned Veniti for one of its devices that looks to treat venous disease. Veniti was approved for its Vici Venous Stent System, which is a stent that is particularly designed for veins. Veniti has utilized funds from its $9.7 million Series B funding round in June 2013 to help formulate the device that is al
DALLAS and NEW YORK, July 22, 2014/ PRNewswire/ ACCESS PHARMACEUTICALS, INC., a developer of new products for oncology supportive care, announced today that it has received 510 marketing clearance from the U.S. Food and Drug Administration for ProctiGard?, its novel treatment for symptomatic management of rectal mucositis. The Company indicated
Cytonics Corporation has announced that an Investigational New Drug application for a phase I/II clinical trial of the company's APIC Cell-Free System has been approved by the FDA. The system is indicated for the rapid preparation of concentrated protease inhibitors in plasma, specifically Alpha-2-Macroglobulin, for the treatment of mild to moderat
Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that the U.S. Food and Drug Administration, or the FDA, cleared Galmed's Investigational New Drug, or IND, applicatio
Halozyme Therapeutics, Inc. today announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed to with the FDA in June. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronid
/CNW/- Spectral Diagnostics Inc. today announced that at the special meeting of shareholders of the Corporation held earlier today, Shareholders overwhelmingly approved the terms of the previously announced proposed non-brokered private placement of the Corporation of up to $18.2 million. FDA approval for its lead theranostics product for the treat
Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510 clearance to market its ARROW-Clark? VectorFlow? Chronic Hemodialysis Catheter. Timothy Clark, M.D., the VectorFlowTM Catheter features a symmetrical tip design that allows ease of placement and sustained high
Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510 clearance to market its ARROW-Clark? VectorFlow? Chronic Hemodialysis Catheter. Teleflex is a leading global provider of specialty medical devices for a range of procedures in critical care and surgery.
By a News Reporter-Staff News Editor at Biotech Business Week Beike Biotechnology Co., Ltd. has officially been accepted into the approval process for the Chinese Food and Drug Administration for the use of human umbilical cord derived mesenchymal stem cells for clinical translation and treatment of Systemic Lupus Erythamatosus. For three months
Boston Scientific Corporation has received FDA approval for the REBEL? Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease. The REBEL Stent System expands the Boston Scientific family of stents featuring its proprietary platinum chromium alloy and a customized st
WASHINGTON- Boston Scientific Corp. announced that it has received FDA approval for the REBEL Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease. The company announced CE Mark for the Rebel Stent System in February. The REBEL Stent System expands the Boston Scientif
CASI Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that China's Food and Drug Administration has approved the Company's application to conduct a Phase II clinical trial in triple-negative breast cancer patients in China for its proprietary drug.
By a News Reporter-Staff News Editor at Pharma Business Week Anacor Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the New Drug Application for KERYDIN? topical solution, 5%, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. "We are pleased to announce t
According to a release, the FDA approval marks a significant expansion of Octapharma's U.S. immune globulin therapy portfolio. Octapharma USA is a subsidiary of Octapharma AG, a global human protein products manufacturer, and since 2004 has been marketing Octagam 5 percent to treat Primary Humoral Immunodeficiency. "The FDA approval of Octagam 10
By a News Reporter-Staff News Editor at Pharma Business Week Par Pharmaceutical Companies, Inc. announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fluphenazine decanoate injection, USP 25 mg/mL. Fluphenazine decanoate injection is a long-acting parenteral antipsych
By a News Reporter-Staff News Editor at Pharma Business Week Perrigo Company announced that it was the first to receive final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg, the store brand equivalent to Advil Congestion Relief Tablet
By a News Reporter-Staff News Editor at Pharma Business Week Quantel Medical announced FDA 510 clearance for its Optimis Fusion? integrated laser platform. The Optimis Fusion system combines advanced selective laser trabeculoplasty photoregeneration therapy and traditional YAG photodisruption treatments to offer ophthalmologists a versatile...
By a News Reporter-Staff News Editor at Pharma Business Week QUBYX, an expert in medical imaging and color calibration fields, has announced that the bundle of PerfectLum DICOM calibration application and Dell UltraSharp U3014 has received the Food& Drug Administration 510 market clearance. Cleared by the FDA, PerfectLum and Dell U3014 bundle wil