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 The leading web portal for pharmacy resources, news, education and careers June 25, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - June 25, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 76     Next >>     Go To Page:

6/25/17 - New FDA-Cleared Smart Heart Monitor Keeps the Cardiologist a Heartbeat Away
By a News Reporter-Staff News Editor at Heart Disease Weekly Eko Devices, the leader in mobile acoustic cardiac monitoring tools, has received FDA clearance to market its latest innovation, DUO- a combined digital stethoscope and electrocardiogram. The portable cardiac device was inspired by cardiologists' demand for more effective monitoring too
6/24/17 - FDA Approves CSL Behring`s Self-Administered C1 Esterase Inhibitor HAE Prophylactic [Syrian Arab News Agency]
The FDA approved CSL Behrings subcutaneously administered C1 esterase inhibitor, Haegarda, for routine use in preventing hereditary angioedema attacks in adolescent and adult patients. The FDA approval of Haegarda is an important milestone for the HAE community because it addresses the primary need of patients: to effectively prevent debilitating H
6/24/17 - Genentechs subcutaneous rituximab approved in US [Sport360]
With cheaper biosimilars of the original Rituxan formulation edging closer to the US market, Genentechs owner Roche is looking for ways to maintain sales. Rituximab biosimilars have already been approved in Europe, where the subcutaneous formulation was approved last year. The FDA noted that the US label will include the following previously approv
6/24/17 - Roches Top-Selling Cancer Drug Approved in Faster Injection Form [T-break Tech (Middle East)]
The U.S. Food and Drug Administration approved Rituxan Hycela for subcutaneous injection. The FDA approval is for the treatment of adults with three blood cancers: previously untreated or relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously treated chronic lymphocytic leukemia.
6/24/17 - U.S. FDA Approves Bevyxxa (betrixaban) First and Only Anticoagulant for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients [Sudan Tribune]
-Portola Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration has approved Bevyxxa, the first and only anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe...
6/23/17 - FDA Approves First Subcutaneous C1 Esterase Inhibitor to Treat Rare Genetic Disease
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. HAE, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the U.S. People with HAE can develop rapid swelling of the hands, feet, limbs, face,
6/23/17 - FDA Approves HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]), First and Only Subcutaneous Preventive Treatment for Hereditary Angioedema
KING OF PRUSSIA, Pa., June 23, 2017/ PRNewswire/ Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration has approved HAEGARDA , the first and only subcutaneous therapy indicated for routine prophylaxis to prevent hereditary angioedema attacks in adolescent and adult patients. "The FDA approval of H
6/23/17 - FDA approves optical imaging agent to assist in resection of high-grade glioma [Sudan Tribune]
The FDA approved aminolevulinic acid hydrochloride as an optical imaging agent indicated for patients with gliomas as an adjunct for the visualization of malignant tissue during surgery, according to the agents manufacturer. Patients take the oral compound 3 hours before undergoing surgery, so the drug reaches the brain tumor and is metabolized int
6/23/17 - FDA approves Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection in certain blood cancers
Basel Roche announced today that the US Food and Drug Administration approved Rituxan Hycela (TM) for subcutaneous injection, for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously
6/23/17 - Novartis combination targeted therapy Tafinlar + Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC) [Tehran Times (Iran)]
Basel, June 22, 2017- Novartis today announced the US Food and Drug Administration approval of Tafinlar in combination with Mekinist to treat patients with metastatic non-small cell lung cancer whose tumors express the BRAF V600E mutation. The FDA granted Tafinlar+ Mekinist Breakthrough Therapy designation in July 2015 for the treatment of patients
6/23/17 - Novartis: FDA Approves Tafinlar Plus Mekinist For BRAF V600E-mutant NSCLC
BASEL- Novartis announced the US Food and Drug Administration or FDA approval of Tafinlar in combination with Mekinist to treat patients with metastatic non-small cell lung cancer whose tumors express the BRAF V600E mutation. The FDA also approved the Oncomine Dx Target Test to identify BRAF V600E mutations in eligible patients. The FDA granted Taf
6/23/17 - Portola Receives FDA Approval For Bevyxxa
The FDA has approved Portola Pharmaceuticals Inc' s BevyxXa, a blood-thinner for acutely ill patients not undergoing surgery. Despite relatively weak data from its phase III clinical trials, Portola's push for FDA approval has paid off. "We are grateful to the patients who participated in our trials, the FDA, our academic collaborators and investi
6/23/17 - Roche receives FDA approval for fourth-generation HIV combination antigen-antibody assay allowing detection of infection with high sensitivity and specificity
Roche announced today that its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay, has received FDA PMA approval from the U.S. Food and Drug Administration. "The approval of this highly sensitive and specific assay demonstrates our ongoing commitment of expanding Roche's already broad testing menu for infect
6/23/17 - Shire receives FDA approval for Mydayis to treat attention deficit hyperactivity disorder [Arab News (Saudi Arabia)]
Biotechnology company Shire has received the US Food and Drug Administration approval for Mydayis for the treatment of attention deficit hyperactivity disorder. The once-daily Mydayis treatment comprises three different types of drug-releasing beads, and is used for ADHD patients aged 13 years and above. It cannot be used on children aged 12 years
6/23/17 - SUPERNUS PHARMACEUTICALS INC FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits
On June 21, 2017, Supernus Pharmaceuticals, Inc. issued a press release announcing that its partner Shire has received U.S. Food and Drug Administration approval for MydayisTM, a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder.
6/23/17 - U.S. FDA Approves Bevyxxa (betrixaban)First and Only Anticoagulant for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients
Portola Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration has approved Bevyxxa, the first and only anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe
6/23/17 - US FDA approves Glenmark Pharma`s drug for overactive bladder [Sudan Tribune]
Glenmark Pharmaceuticals on Thursday said the US health regulator has granted tentative approval for tablets used for treatment of overactive bladder. The company has been granted tentative approval by the United States Food and Drug Administration for Solifenacin Succinate tablets, 5 mg and 10 mg, Glenmark Pharmaceuticals said in a BSE filing.
6/22/17 - BD Receives FDA 510K Clearance for Molecular Test for Harmful Intestinal Bacteria Causing Infectious Diarrhea
By a News Reporter-Staff News Editor at Politics& Government Week BD, a leading global medical technology company, announced that its newly developed molecular test for detecting harmful intestinal bacteria causing infectious diarrhea has received 510 clearance from the U.S. Food and Drug Administration. Joel Mortensen, managing director for Mort
6/22/17 - BD Receives FDA 510k Clearance for New Line of Customizable, 3.0mm Micro-Laparoscopic Instruments
Release date- 21062017- FRANKLIN LAKES, N.J- BD, a leading global medical technology company, today announced that its new line of Snowden PencerTM 3.0 mm laparoscopic ergonomic take apart instruments received U.S.. Food and Drug Administration 510 clearance for use in laparoscopic surgery. 'Minimally invasive micro-laparoscopic surgery is a steadi
6/22/17 - FDA Approves Darzalex Combo Therapy for Previously Treated Multiple Myeloma Patients [Sport360]
The U.S. Federal Drug Administration has approved a combination of the immunotherapies Darzalex, Pomalyst and dexamethasone as a multiple myeloma treatment, according to Darzalexs developer, Janssen Biotech. The combo offers a new option for patients who fail to respond to two lines of therapy that include Revlimib and a proteasome inhibitor like V
6/22/17 - FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies
The U.S. Food and Drug Administration has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing- based test that simultaneously screens tumor samples for biomarkers associated with three FDA- approved therapies for non-small cell lung cancer. Following FDA approval, results from analysis of three of these
6/22/17 - FDA Approves Genentech's RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology
SAN DIEGO, June 22, 2017/ PRNewswire/ Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the U.S. Food and Drug Administration has approved Genentech's RITUXAN HYCELATM, a combination of rituximab and Halozyme's hyaluronidase human ENHANZE technology, for subcutaneou
6/22/17 - FDA approves new Shire drug for ADHD [T-break Tech (Middle East)]
Federal regulators Tuesday approved a new drug developed by Shire plc to treat attention deficit hyperactivity disorder in patients 13 years and older. Shire, a leading maker of rare disease medicines, said it plans to make the newly approved ADHD drug available for commercial use in the United States in the third quarter. In a safety notice requir
6/22/17 - FDA approves quicker-to-administer drug for blood cancers
The Roche Group's Rituxan, on the market for 20 years, is administered in a hospital or clinic through an intravenous drip that can take several hours. On Thursday, the Food and Drug Administration approved the Swiss drugmaker's new version, Rituxan Hycela. Rituxan, which will still be available, is Roche's top seller.
6/22/17 - FDA Approves RITUXAN HYCELA (Rituximab and Hyaluronidase Human) for Subcutaneous Injection in Certain Blood Cancers
Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration approved RITUXAN HYCELA? for subcutaneous injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously
Articles(s): 1 - 25 of 76     Next >>     Go To Page:


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