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 The leading web portal for pharmacy resources, news, education and careers July 23, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 23, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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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: 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 - 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 - 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
6/22/17 - FDA Clears Insulin Algorithms Comprehensive Insulin-Titration Software For Clinicians
The U.S. Food& Drug Administration has cleared as a Class II medical device Insulin Algorithms' decision-support software, which helps clinicians manage every type of insulin for diabetes treatment. With FDA clearance and its previous CE registration, Insulin Algorithms' decision-support software can now be marketed and sold in both the United St
6/22/17 - Gauss Surgical Receives FDA Clearance for Second Generation Triton for Real-Time Monitoring of Surgical Blood Loss
Gauss Surgical, Inc. announced today that the company received U.S. Food and Drug Administration clearance for its second generation Triton OR system, a mobile platform for accurate, real-time estimation of surgical blood loss. Measurement of blood loss is a challenge that has plagued surgical departments for decades. The FDA first cleared the Trit
6/22/17 - GNW-News: Novartis combination targeted therapy Tafinlar + Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC) (english)
Novartis combination targeted therapy Tafinlar + Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer. Novartis International AG/ Novartis combination targeted therapy Tafinlar + Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer. Basel, June 22, 2017- Novartis
6/22/17 - Lannett Receives Approval For Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg And 10 mg/300 mg
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg, the therapeutic equivalent to the reference standard drug, Hydrocodone Bitartrate and Acetaminophe
6/22/17 - Molecular Test for Common Causes of Vaginitis Receives FDA Approval
Johns Hopkins researchers report that a molecular diagnostic test accurately distinguishes among the three most common causes of vaginitis, an inflammation of vaginal tissue they say accounts for millions of visits to medical clinics and offices in the U.S. each year. "Overall, the disease prevalence identified by the traditional and the new molec
6/22/17 - Morgan Stanley rates COH as Equal-weight
The company's N7 speech processor appears to have received US FDA approval although the timing on its availability is unclear. Equal-weight rating retained. Target is $138. If COH meets the Morgan Stanley target it will return approximately -16%.
6/22/17 - Neos, facing criticism, wins approval for another easy-to-take pediatric ADHD medication [T-break Tech (Middle East)]
Theres a new FDA- approved ADHD medication on the scene, and its one maker Neos Therapeutics thinks will put it in prime market position. Monday, U.S. regulators green-lighted the Texas drugmakers Cotempla, an extended-release tablet that disintegrates in the mouth, for patients ages 6 to 17.. Now, physicians will be able to choose a an extended-re
6/22/17 - Novartis combination targeted therapy Tafinlar + Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC)
The FDA granted Tafinlar+ Mekinist Breakthrough Therapy designation in July 2015 for the treatment of patients with advanced or metastatic BRAF V600E mutation-positive NSCLC who received previous treatment with chemotherapy. "The approval of Tafinlar+ Mekinist makes BRAF V600E the fourth actionable genomic biomarker in metastatic NSCLC along wi
6/21/17 - Alembic receives U.S. FDA approval for Candesartan Cilexetil Tablets [India Infoline News Service]
Alembic Pharmaceuticals has received US Food& Drug Administration approval for its Abbreviated New Drug Application for Candesartan Cilexetil Tablets, 32 mg, the company informed the bourses on Wednesday. Alembic Pharmaceuticals has received US Food& Drug Administration approval for its Abbreviated New Drug Application for Candesartan Cilexetil...
6/21/17 - Avera Health Receives FDA Approval for Clinical Trials of Novel Therapy for Peripheral Vascular Disease
Avera Health announces an exciting development that will contribute toward South Dakota's growing biotech industry. NVS therapy, which marries balloon angioplasty with a pharmaceutical process, is the first combination product for vascular medicine to enter the U.S. FDA approval process. "We are thrilled that this innovation has reached the point
6/21/17 - BD Receives FDA 510(k) Clearance for New Line of Customizable, 3.0mm Micro-Laparoscopic Instruments [Sport360]
BD, a leading global medical technology company, today announced that its new line of Snowden-Pencer 3.0 mm laparoscopic ergonomic take-apart instruments received U.S. Food and Drug Administration 510 clearance for use in laparoscopic surgery. The new line of Snowden-Pencer 3.0 mm laparoscopic ergonomic take-apart instruments are designed for...
6/21/17 - Clarify Medical Core Technology Receives FDA Clearance
By a News Reporter-Staff News Editor at Biotech Week Clarify Medical, Inc. announced that it has received FDA Market Clearance for the Clarify Medical Phototherapy System, the core technology of its Clarify Home Light Therapy service, which it plans to offer to patients in November. "For people with chronic skin conditions that respond to light
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