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 The leading web portal for pharmacy resources, news, education and careers September 21, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 21, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 84     Next >>     Go To Page:

9/21/17 - 18 Stocks Moving In Thursday's Pre-Market Session
Gainers Calgon Carbon Corporation rose 62.1 percent to $21.40 in pre-market trading after the company agreed to be acquired by Kuraray at $21.50 per share in cash. BioCryst Pharmaceuticals, Inc. shares rose 12 percent to $5.90 in the pre-market trading session after the company disclosed that its RAPIVAB received the FDA approval for a pediatric...
9/21/17 - BioCryst's RAPIVAB (peramivir injection) Receives FDA Approval for a Pediatric Indication
BioCryst Pharmaceuticals, Inc. a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced today that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for RAPIVAB, an intravenous neuraminidase inhibitor, extending its availability for the.
9/21/17 - Brainlab announces FDA clearance for two new indication-specific radiosurgery software applications
Brainlab announced today that it has received FDA clearance for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-tailored planning of radiosurgery treatments for indications of the spine and brain. With FDA clearance of these software modules, the Brainlab Elements portfolio of applications that facilit
9/21/17 - FDA Clears First Duodenoscope With Disposable Distal Cap
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in
9/21/17 - Perrigo Announces FDA Final Approval For Its AB Rated Generic Version Of Exalgo 32mg Extended Release Tablets
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo 32 mg extended release tablets. Annual market sales for the brand and generic equivalents of Exalgo 32 mg extended release tablets for the 12 months ended July 201
9/20/17 - Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
DANVERS, Mass., 2017-09-21 00:26 CEST Abiomed, Inc., a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration pre-market approval for the Impella RP heart pump. With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular suppor
9/20/17 - Agilent Announces Expanded Use of Cancer Diagnostic in the United States; Dako PD-L1 IHC 28-8 PharmDx Approved for Two New Indications
SANTA CLARA, Calif. Agilent Technologies Inc. today announced that the U.S. Food and Drug Administration has approved the cancer diagnostic known as PD-L1 IHC 28-8 pharmDx for use in cases of urothelial carcinoma and of squamous cell carcinoma of the head and neck. The PDL1 IHC 28-8 pharmDx test enables physicians in the USA to identify which pat
9/20/17 - Amphastar Pharmaceuticals Receives FDA Approval for Sodium Bicarbonate Injection
Amphastar Pharmaceuticals, Inc. announced that on September 19, 2017, the U.S. Food and Drug Administration granted approval of the company s abbreviated new drug application for Sodium Bicarbonate injection 8.4% in the 50 mL Luer-Jet Prefilled Syringe System. Net revenues for the company s sodium bicarbonate injection for the year ended
9/20/17 - Development of an approved Food and Drug Administration (FDA) TBI Assay Cartridge for the i-STAT- , using UCHL1 and GFAP protein biomarkers.
Office Address: Department of the Army; U.S. Army Medical Research Acquisition Activity; Attn: MCMR-AAA820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014. U.S. Army Medical Research Acquisition Activity. U.S. Army Medical Research Acquisition Activity.
9/20/17 - Glenmark gets USFDA nod for generic skin ointment [All Iraq News Agency (AIN)]
Glenmark Pharmaceuticals Inc, a subsidiary of the company, has received final approval from the US Food and Drug Administration for Desonide ointment, the company said in a statement. As per the latest IMS Health sales data, the product had annual sales of around USD 23.4 million. Glenmark`s current portfolio consists of 124 products authorised for
9/20/17 - Kind Health Group, An Innovative Women's Health Practice, Opens In Encinitas
Dr. Nanos is building this practice on the belief that an individually customized path is essential to a woman's wellness and balanced health. The MonaLisa Touch, an in-office procedure that is non-hormonal, virtually painless and requires no anesthesia, received FDA clearance 2014. Dr. Nanos is one of the first physicians in the San Diego area to
9/20/17 - MediPoint: Global Patient Monitoring Equipment Market to Grow at a CAGR of 8.93% During 2017-2021
For instance, Dexcom developed the Dexcom G5 mobile continuous glucose monitoring device, a mobile system, that sends glucose readings to a compatible smartphone every 5 minutes. In October 2014, the company received the FDA approval for its mobile application Dexcom SHARE, which is used in Dexcom G4 PLATINUM CGM system.The global patient monitorin
9/20/17 - Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management
Release date- 19092017- DUBLIN- Medtronic plc today announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform can record and track patient activity 24/ 7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjec
9/20/17 - Sapheneia / Scannerside Announces FDA 510K Clearance for New 2nd Gen XR 29 Dose Check
By a News Reporter-Staff News Editor at Computer Weekly News Sapheneia and Scannerside received FDA 510 clearance to market their XR-29 DoseCheck solution. "We believe the latest comprehensive solution will be the backbone to solving XR25/29 and beyond upgrades for legacy Scanners," says Paul Stashick, CEO Sapheneia Inc.. Sapheneia has a long su
9/20/17 - Solosec Approved for Treatment of Bacterial Vaginosis [Sport360]
Solosec has been approved by the US Food and Drug Administration for the treatment of bacterial vaginosis in adult women. BV is the most common gynecologic infection in the United States, affecting 21 million women between the ages of 14 and 49, each year. The FDA designated Solosec as a Qualified Infectious Disease Product for the treatment of BV,
9/20/17 - Stryker's Spine Division Receives FDA Clearance for 3D-Printed Tritanium C Anterior Cervical Cage
Stryker s Spine division today announced that its Tritanium C Anterior Cervical Cage, a 3 D-printed interbody fusion cage intended for use in the cervical spine, has received 510 clearance from the U.S. Food and Drug Administration. The Tritanium C Anterior Cervical Cage is constructed from Stryker s proprietary Tritanium In-Growth Technol
9/20/17 - Sun Pharma gets USFDA approval for new label for Odomzo [India Infoline News Service]
Sun Pharmaceutical Industries Ltd announced that one of its wholly-owned subsidiaries has received approval from the US Food and Drug Administration for a new label for Odomzo. Sun Pharmaceutical Industries Ltd announced that one of its wholly-owned subsidiaries has received approval from the US Food and Drug Administration for a new label for Odom
9/20/17 - Sun Pharma Odomzo (Sonidegib) New Label Approval Shows Sustained Duration of Response of 26 Months in Treatment of Locally Advanced Basal Cell Carcinoma
Sun Pharmaceutical Industries Ltd. today announced that one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration for a new label for Odomzo , an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation ther
9/20/17 - Teligent, Inc. Announces FDA Approval of Triamcinolone Acetonide Cream USP, 0.1% [Sudan Tribune]
-Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Companys abbreviated new drug application from the U.S. Food and Drug Administration of Triamcinolone Acetonide Cream USP, 0.1%. Teligent now has twenty-one topical generic pharmaceutical products in the US portfolio, in ad
9/20/17 - Trelegy Ellipta Approved as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Appropriate Patients With COPD in the US
The Chronic Obstructive Pulmonary Disease Foundation issued the following news release:. GlaxoSmithKline plc and Innoviva, Inc. today announced that the US Food and Drug Administration has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term,...
9/19/17 - Agilent Announces Expanded Use of Cancer Diagnostic in the United States; .Dako PD-L1 IHC 28-8 PharmDx Approved for Two New Indications
SANTA CLARA, Calif. Agilent Technologies Inc. today announced that the U.S. Food and Drug Administration has approved the cancer diagnostic known as PD-L1 IHC 28-8 pharmDx for use in cases of urothelial carcinoma and of squamous cell carcinoma of the head and neck. The PDL1 IHC 28-8 pharmDx test enables physicians in the USA to identify which pat
9/19/17 - Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay
SANTA CLARA, Calif.- Agilent Technologies Inc. has announced that it has obtained 510 clearance from the U.S. Food and Drug Administration for the GenetiSure Dx Postnatal Assay: its first comparative genomic hybridization assay for diagnostic use. Previously available only in Europe, U.S. clinical genetic scientists can now use this assay to help i
9/19/17 - Amgen and Allergans anti-cancer biosimilar Mvasi receives FDA approval [All Iraq News Agency (AIN)]
Co-developed by Amgen and Allergan, Mvasi is the first anti-cancer biosimilar to be approved by the FDA and is largely similar to Avastin. Amgen research and development executive vice-president Dr Sean E. Harper said: The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar..
9/19/17 - Arkis BioSciences Achieves FDA Clearance of its CerebroFlo? EVD Catheter with Endexo Technology
Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained FDA clearance of its new external ventricular drainage catheter, CerebroFlo?. Seaver says Arkis plans to introduce the device to the U.S. market at the upcoming annual Congress of Neurological Surgeons, which will be held in Boston, MA, Oct. 7-11
9/19/17 - Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies
Release date- 18092017- Berlin- Bayer announced today that the U.S. Food and Drug Administration has approved copanlisib under the brand name Aliqopa 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The FDA granted approval under the accelerated a
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