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 The leading web portal for pharmacy resources, news, education and careers July 20, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 20, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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7/18/17 - SUMMARY: Senate Subcommittee Approves FY2018 Agriculture Appropriations Bill
WASHINGTON- The fiscal year 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill provides a total discretionary funding level of $20.525 billion, which is $352 million below the fiscal year 2017 enacted level and $4.8 billion above the President's request. U.S. Senator Jeff Merkley, Ranking Member of the Agri
7/18/17 - U.S. Food and Drug Administration Approves Gilead's Vosevi? (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved Vosevi? tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1 a or 3 previously treated wit
7/17/17 - "Cardiologs ECG Analysis Platform" Receives FDA Clearance
By a News Reporter-Staff News Editor at Cardiovascular Week Cardiologs Technologies SAS announced that it has received FDA clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence. The Cardiologs system is also CE-marked in Europe. Arnaud Rosier, cardiac...
7/17/17 - Bristol-Myers Squibb's ORENCIA abatacept Receives FDA Approval for Treatment of Active Psoriatic Arthritis PsA in Adults
By a News Reporter-Staff News Editor at Biotech Business Week Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis 1, a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.3 ORENCIA is approved and available
7/17/17 - FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today approved Nerlynx for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. "HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan," said Richard Pazdur, M.D., director of the FDA
7/17/17 - FDA Clears SaeboVR Virtual ADL Rehabilitation System
SaeboVR, a virtual ADL (activities of daily living) rehabilitation system designed to provide real-life challenges to help neurological patients rehabilitate their upper extremities, has recently received clearance from the US Food and Drug Administration.
7/17/17 - GLENMARK PHARMA GETS USFDA NOD FOR HYPERTENSION MEDICINE
Glenmark Pharmaceuticals has received final approval from the US health regulator for Amlodipine and Olmesartan Medoxomil tablets, used in the treatment of hypertension. Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration for Amlodipine and Olmesartan Medoxomil tablets, 5 mg/20 mg,
7/17/17 - Impax Announces FDA Approval of its AB Rated Generic Concerta (Methylphenidate Hydrochloride) Extended-Release Tablets CII
Impax Laboratories, Inc., a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Concerta Extended-Release tablets USP CII, 18, 27, 36 and 54 mg. "Approval of our AB-rated gener
7/17/17 - Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel Topical Gel, 1.62% Packets
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 AbbVie Inc.' s Androgel Topical Gel, 1.62% packets. Annual market sales for Androgel Topical Gel, 1.62% packets for the 12 months ending May 2017 were approximately $88 m
7/17/17 - Syngenta Receives China Import Approval for Agrisure Duracade Corn Trait
Syngenta announced today that it has received notification of import approval from the Chinese Ministry of Agriculture for its Agrisure Duracade trait. The Agrisure Duracade trait has completed the Food and Drug Administration consultation process, received registration from the Environmental Protection Agency and has been fully deregulated by..
7/17/17 - U.S. Food and Drug Administration Approves Puma's NERLYNX? (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Puma Biotechnology, Inc. today announced that the U.S. Food and Drug Administration has approved NERLYNX?, formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
7/14/17 - Amgen Receives FDA Approval For BLINCYTO [All Iraq News Agency (AIN)]
Today, Amgen announced that it had received FDA approval for its drug BLINCYTO. The FDA had approved the Supplemental Biologics License Application sBLA for BLINCYTO, because of results from two positive clinical trials. The drug was approved because of results from a phase 3 study, known as the TOWER study.
7/14/17 - Apexian Pharmaceuticals Announces FDA Agreement For Inclusion of Chemotherapy Induced Peripheral Neuropathy (CIPN) Indication Under Currently Approved IND [Sudan Tribune]
Apexian Pharmaceuticals, a clinical stage biotechnology company developing novel compounds to treat cancer, today announced that it has received FDA agreement that the currently approved IND can be used to examine Chemotherapy Induced Peripheral Neuropathy as an indication in addition to its anti-tumor effects. Mark Kelley, Apexian`s CSO, has recei
7/14/17 - Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection Vidaza
By a News Reporter-Staff News Editor at Drug Week Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100 mg per vial, Single-Dose Vial, a generic version of Vidaza by Celgene Corporation. Breckenridge submitted the ANDA with its development and manufacturing partner Natco Phar
7/14/17 - Digestive Care, Inc. Announces FDA Approval of a 24,000 USP Lipase Units Capsule of PERTZYE(R) (pancrelipase) Delayed Release Capsules to Treat Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis and Other Conditions
Digestive Care, Inc. and its marketing partner to support the U.S. cystic fibrosis community, Chiesi, today announced U.S. Food and Drug Administration approval of PERTZYE in a 24,000 USP lipase units capsule. "Along with our partner, Chiesi, we feel it is important to offer options for enzyme delivery to those with EPI due to CF," said Tibor S
7/14/17 - GSK ships 2017-18 seasonal influenza vaccines for US market
The US Centers for Disease Control and Prevention recommends flu vaccination as the single best measure for flu prevention. The CDC has a routine recommendation for people over the age of 6 months to get a flu vaccination each year as the first and most important step in protecting against this disease. 1,2. In November 2016, GSK received approval
7/14/17 - Janssen Announces U.S. Fda Approval of Tremfya (Guselkumab) for Treatment of Moderate to Severe Plaque Psoriasis
Johnson and Johnson issued the following news release:. Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration has approved TREMFYA for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. "TREMFYA represents a significant milestone in the treatme
7/14/17 - JOHNSON & JOHNSON - JANSSEN ANNOUNCES U.S. FDA APPROVAL OF TREMFYA FOR THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS
Release date- 13072017- Horsham, PA- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration has approved TREMFYA for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 'TREMFYA represents a significant milestone in the treatment of moderate to se
7/14/17 - Lannett Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Cyproheptadine Hydrochloride Syrup 2 mg/5 mL, the therapeutic equivalent to the reference standard drug, Cyproheptadine Hydrochloride Syrup by Lyne Laboratories, Inc. The product was previously mar
7/14/17 - Novel Gene Therapy for Leukemia Clears FDA Panel [Tehran Times (Iran)]
A panel of outside experts convened by the FDA voted 10-0 Wednesday to recommend the approval of Novartis CAR-T therapy, called CTL019, for the treatment of children and young adults with advanced leukemia. The FDA is expected to make a final decision on approval by Oct. 3. The FDA is also reviewing a CAR-T from Kite Pharma for the treatment of adu
7/14/17 - Sihuan Pharm's new drug gets approval for clinical trials [ET Net News (China)]
Sihuan Pharmaceutical said the China Food. and Drug Administration has granted approval of Phase I-III clinical trials of Birociclib,. Sihuan Pharmaceutical Co., Ltd. and Shandong XuanZhu Pharma Co., Ltd..
7/14/17 - USFDA advisory panel unanimously approves first ever leukemia gene treatment [T-break Tech (Middle East)]
The committee recommended that the FDA take the necessary measures to approve the drug, which has been clinically tested. In the case the FDA approves the launch of the drug, called Tisagenlecleucel, it will be the first ever leukemia drug introduced on market. Tisagenlecleucel is an adoptive immunocellular cancer therapy that uses autologous perip
7/13/17 - FDA OKs new Johnson & Johnson treatment for psoriasis
U.S. regulators approved a new psoriasis drug from Johnson& Johnson Thursday, giving people with the itchy and painful condition another treatment option. Johnson& Johnson said that in one patient study, about seven in 10 patients getting the drug, Tremfya, had clear or nearly clear skin after 24 weeks of treatment. Johnson& Johnson, based in Ne
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