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 The leading web portal for pharmacy resources, news, education and careers May 30, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 30, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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4/29/17 - China FDA Approves Countrys First All-Oral Regimen for Chronic Hepatitis C, Daklinza (daclatasvir) in Combination with Sunvepra (asunaprevir) [T-break Tech (Middle East)]
Bristol-Myers Squibb Company announced today that the China Food and Drug Administration has approved a direct-acting antiviral regimen comprised of Daklinza and Sunvepra, for the treatment of treatment-naive or- experienced patients, with or without compensated cirrhosis, infected with genotype 1 b chronic hepatitis C virus. In addition, Daklinza
4/29/17 - Novartis: FDA Approves Rydapt To Treat FLT3-mutated Acute Myeloid Leukemia
BASEL- Novartis announced the US FDA has approved Rydapt for two indications. The first indication is for the treatment of acute myeloid leukemia in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive, as detected by an FDA- approved test, in combination with chemotherapy. The FDA approval is based on the Phase III RATIFY
4/28/17 - China FDA Approves Country's First All-Oral Regimen for Chronic Hepatitis C, Daklinza (daclatasvir) in Combination with Sunvepra (asunaprevir)
Bristol-Myers Squibb Company announced today that the China Food and Drug Administration has approved a direct-acting antiviral regimen comprised of Daklinza and Sunvepra , for the treatment of treatment-naive or- experienced patients, with or without compensated cirrhosis, infected with genotype 1 b chronic hepatitis C virus.
4/28/17 - CPAC COX RapidHeat Sterilizer Features FDA-Cleared Rapid Cycles
Wrapped instruments and handpieces are FDA cleared for 12 minutes.
4/28/17 - FDA approves 1st targeted drug for certain leukemia patients
The Food and Drug Administration approved the drug for adults with acute myeloid leukemia, or AML, who have a genetic mutation called FLT3. Richard Stone of Dana-Farber Cancer Institute in Boston, said in a statement. He led testing of Rydapt, funded by the drug's maker, Novartis Pharmaceuticals Corp. Read more on Colorado Springs Gazette.
4/28/17 - FDA approves first treatment for a form of Batten disease
Release date- 27042017- The U.S. Food and Drug Administration today approved Brineura as a treatment for a specific form of Batten disease. Brineura is the first FDA- approved treatment to slow loss of walking ability in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2, also known as
4/28/17 - FDA approves more drugs, and faster, than Europe, study says [Malta Independent, The]
"It's an urban myth" that the FDA is slower than other countries to clear promising treatments for patients, said the agency's longtime cancer drugs chief, Dr. The new research compared how new drugs fared before the FDA and the European Medicines Agency between 2011 and 2015. The FDA approved more drugs than the Europeans- 170 versus 144- with a m
4/28/17 - FDA Approves Radius Health's TYMLOS? (abaloparatide), a Bone Building Agent for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Radius Health, Inc., a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced that the US Food and Drug Administration has approved TYMLOS injection for the treatment of postmenopausal women with osteoporosis a
4/28/17 - FDA Expands Approved Use of Stivarga to Treat Liver Cancer
This is the first FDA- approved treatment for a liver cancer in almost a decade. "Limited treatment options are available for patients with liver cancer," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Exc
4/28/17 - FDA Oks BioMarin's Brineura As Treatment For Specific Form Of Batten Disease
WASHINGTON- BioMarin Pharmaceutical Inc. said Thursday that the U.S. Food and Drug Administration approved Brineura or cerliponase alfa to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 or CLN2, also known as tripeptidyl peptidase 1 or TPP1 deficiency.
4/28/17 - GNW-News: Novartis receives FDA approval for Rydapt in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM) (english)
Novartis receives FDA approval for Rydapt in newly diagnosed FLT3-mutated acute myeloid leukemia and three types of systemic mastocytosis. Novartis International AG/ Novartis receives FDA approval for Rydapt in newly diagnosed FLT3-mutated acute myeloid leukemia and three types of systemic mastocytosis. Processed and transmitted by Nasdaq...
4/28/17 - Gout Therapeutics Market to Reach $8.3 Billion by 2025 - Key Vendors are Takeda Pharmaceutical, Novartis, Savient Pharmaceuticals, AstraZeneca, GlaxoSmithKline, Merck, Teijin Pharma & Regeneron - Research and Markets
Research and Markets has announced the addition of the "Gout Therapeutics Market, 2014- 2025" report to their offering. In December 2015, AstraZeneca's product, Zurampic, in combination with xanthine oxidase inhibitor received an approval from the U. S. FDA to treat gout. Later in February 2016, the European Commission approved the drug throughout
4/28/17 - Haag-Streit Gains FDA Approval for Fundus Module 300, Will Showcase at ASCRSASOA 2017 [Algeria Press Service]
-Optical instruments manufacturer Haag-Streit is pleased to announce it has received FDA approval for its Fundus Module 300 slit lamp attachment in the United States. This innovative product works well with select Haag-Streit slit lamps, and unlike handheld fundus camera devices, attaches directly to the slit lamp for full, stable integration with
4/28/17 - INTERSON ANNOUNCES USB ULTRASOUND ARRAYS FOR TELEMEDICINE
Pleasanton, CA Interson announced at the American Telemedicine trade show in Orlando Florida, ATA 2017, their newest USB ultrasound arrays for telemedicine has received 510 clearance from the U.S. Food and Drug Administration. Interson is the market leader in open-architecture USB ultrasound imaging probes since announcing their first USB ultraso
4/28/17 - Invivoscribe Receives FDA Approval for the LeukoStrat CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt and is the First Companion Diagnostic for AML
Due to current labeling for the FDA approved test, FLT3 mutation testing with LeukoStrat CDx FLT3 Mutation Assay is exclusively performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for the Novartis drug Rydapt
4/28/17 - Lupin receives USFDA approval for generic Benicar tablets [India Infoline News Service]
Pharma major, Lupin Limited, on Friday announced that it has received final approval for its Olmesartan Medoxomil tablets, 5 mg, 20 mg and 40 mg from the United States Food and Drug Administration, to market generic version of Benicar tablets, 5 mg, 20 mg and 40 mg. Pharma major, Lupin Limited, on Friday announced that it has received final approva
4/28/17 - Mallinckrodt Data from New Company-Sponsored Studies Presented at American Academy of Neurology 69th Annual Meeting
Findings from the IS study indicate treatment with H.P. "Mallinckrodt continues to build on the knowledge surrounding IS and MS relapse, two disease categories for which Acthar is an important treatment option," said Tunde Otulana, Chief Medical Officer at Mallinckrodt. Acthar Gel has been approved by the U.S. Food and Drug Administration as a fir
4/28/17 - Medeor Therapeutics Receives FDA Clearance of IND Application and Special Protocol Assessment for Pivotal Clinical Study of MDR-101
Medeor Therapeutics, Inc., a private, clinical-stage biotechnology company dedicated to the discovery, development and commercialization of personalized cellular immunotherapies, today announced it has received clearance from the U.S. Food and Drug Administration for an Investigational New Drug application for the company s lead product candid
4/28/17 - Novartis receives FDA approval for Rydapt in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM)
Novartis announced today the US Food and Drug Administration has approved Rydapt for two indications. The first indication is for the treatment of acute myeloid leukemia in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive, as detected by an FDA- approved test, in combination with chemotherapy 3. This approval follo
4/28/17 - Takeda Announces FDA Accelerated Approval of ALUNBRIGTM (brigatinib)
CAMBRIDGE, Mass.& OSAKA, Japan Takeda Pharmaceutical Company Limited today announced that ALUNBRIG? has received Accelerated Approval from the U.S. Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.
4/28/17 - Venus Medtech's TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China
Venus Medtech Inc., announced on April 25th that its transcatheter aortic valve system- Venus A-valve- has been approved by China Food and Drug Administration for sale in China. This marks the first-ever CFDA approved Transcatheter Aortic Valve Implantation device in China, and the official commercialization of the Venus A-valve in China.
4/27/17 - At Vance Thompson Vision, New Dry Eye FDA Approval Leads Where No One Expected. Up Your Nose.
Allergan recently announced that it has received FDA approval for TrueTear? Intranasal Tear Neurostimulator, the first and only FDA- cleared device developed to temporarily increase tear production in adult patients. "The FDA approval of the TrueTear? brings new hope to patients suffering from dry eye," says Dr. "With the approval, we can n
4/27/17 - Bausch + Lomb Receives 510 Clearance from FDA for Vitesse, the Only Hypersonic, Open Port Vitrectomy System
Release date- 26042017- BRIDGEWATER, NJ- Bausch+ Lomb, a leading global eye health company, today announced that it has received 510 clearance from the U.S. Food and Drug Administration for Vitesse, the first and only hypersonic, 100% open port vitrectomy system. 'The ongoing development of Vitesse is an exciting example of Bausch+ Lomb's commitmen
4/27/17 - Bausch + Lomb Receives 510(k) Clearance from FDA for Vitesse, the Only Hypersonic, Open Port Vitrectomy System
Release date- 26042017- BRIDGEWATER, NJ- Bausch+ Lomb, a leading global eye health company, today announced that it has received 510 clearance from the U.S. Food and Drug Administration for Vitesse, the first and only hypersonic, 100% open port vitrectomy system. 'The ongoing development of Vitesse is an exciting example of Bausch+ Lomb's commitmen
4/27/17 - Bayer Receives FDA Approval for Stivarga (regorafenib) for the Second-Line Systemic Treatment of Liver Cancer
Bayer announced today that the U.S. Food and Drug Administration approved Stivarga tablets for the second-line treatment of patients with hepatocellular carcinoma who have been previously treated with Nexavar . 2 Stivarga is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients. 2 I
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