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 The leading web portal for pharmacy resources, news, education and careers April 26, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 26, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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4/25/18 - Align Technology Announces China Food and Drug Administration Approval for the iTero Element Intraoral Scanner
Align Technology, Inc. today announced that the company has received approval from the China Food and Drug Administration to market the iTero Element intraoral scanner in China.. The market opportunity in China is huge and it remains the single largest country market for Align outside of the United States, said Julie Tay, Align Technology s
4/25/18 - ANI Pharmaceuticals Announces Approval of Morphine Sulfate Oral Solution
BAUDETTE- ANI Pharmaceuticals, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Morphine Sulfate Oral Solution 10 mg/5mL, 20 mg/5mL and 100 mg/5mL. The current annual U.S. market for this product is approximately $17 million, according to Iqvia/IMS Health.
4/25/18 - AstraZeneca - US FDA approves TAGRISSO as 1st-line treatment for EGFR-mutated non-small cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration has approved TAGRISSO for the 1st- line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor mutations, as detected by an FDA- approved test. The approval is based on results from the Phase III FLAURA trial, which were
4/25/18 - Bausch + Lomb Receives 510(K) Clearance From FDA For BOSTON Scleral Lens Case
BRIDGEWATER- Bausch+ Lomb, a leading global eye health company, today announced that the company's Specialty Vision Products business has received 510 clearance from the U.S. Food and Drug Administration for the Boston scleral lens case, a storage case developed specifically for scleral lenses. The Boston scleral lens case is indicated for use with
4/25/18 - Clinical Trials Supporting FDA Approvals of New Medications for Life-Threatening Diseases Must Be Held to Higher Standard
The use of placebos in clinical trials testing new medications for life-threatening diseases- for which treatments proven to be effective already are available- is widespread and can put human subjects at increased risk of harm, according to a new study by Public Citizen's Health Research Group. The study was published today online in Open Access J
4/25/18 - FDA accepts for review Supplemental Biologics License Application for 0.5 mL dose of Fluzone Quadrivalent (Influenza Vaccine) in children 6-35 months of age
The U.S. Food and Drug Administration has accepted for review a supplemental Biologics License Application to expand the age indication of the 0.5 mL dose of Sanofi Pasteur's Fluzone Quadrivalent to include children 6 through 35 months of age. Per the Prescription Drug User Fee Act, the target action date is January 28, 2019. David P. Greenber
4/25/18 - Glenmark receives ANDA approval for Tacrolimus Ointment, 0.1%
Glenmark's current portfolio consists of 132 products authorized for distribution in the U.S. marketplace and 61 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio
4/25/18 - U.S. FDA Clears Pluristem's Phase III Study in Treatment of Muscle Injury Following Hip Fracture Surgery
Pluristem Therapeutics a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration has cleared Pluristem s Investigational Drug Application for a Phase III study of its PLX-PAD cell therapy in the treatment of muscle injury following surgical repair of the hip joint due to fracture.
4/25/18 - Varian Launches Velocity 4.0 Cancer Imaging Software with Selective Internal Radiation Therapy Dosimetry Analysis
By a News Reporter-Staff News Editor at Computer Weekly News Varian announced a new version of its Velocity? cancer imaging software which includes Rapidsphere?, a module for Y90 Selective Internal Radiation Therapy dosimetry analysis. Velocity 4.0 and the Rapidsphere module have received FDA 510 clearance. Rapidsphere is an integrated image-
4/24/18 - CANbridge Receives Approval to Commence CAN008 Phase II/III Trial in Glioblastoma Multiforme GBM in China
By a News Reporter-Staff News Editor at China Weekly News CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the China Food and Drug Administration has approved the Investigational New Drug application for a Phase II/III clinical study of lead candidate, CAN00
4/24/18 - FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
The U.S. Food and Drug Administration today approved Crysvita, the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets. 'XLH differs from other forms of rickets in that vitamin D therapy is not effective,' stated Julie Beitz, M.D., director of the Office of Drug Ev
4/24/18 - First drug approved for most common inherited kidney disease
The U.S. Food and Drug Administration has approved the first drug to slow kidney decline in patients with the most common inherited kidney disease. Jynarque, from Japan's Otsuka Pharmaceutical, was approved Tuesday for a form of polycystic kidney disease. The progressive genetic disorder is the fourth-leading cause of kidney failure.
4/24/18 - Interim Report January-March 2018
The study design for PledOx Phase III program has been approved by the UK Medicines Agency MHRA and accepted by the US FDA and the Central Ethics Committee of the United States PledOx shows favorable safety and tolerability profile in the SUNCIST Phase I study in Japanese healthy volunteers Delayed delivery of study drug for the PledOx pha
4/24/18 - Kindred Biosciences Provides Updates on Pending Drug Approvals
Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has received a response from the Food and Drug Administration for the Chemistry, Manufacturing, and Controls technical section for Zimeta IV for the control of fever in horses. The FDA has no additional questions or re
4/24/18 - Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions
DUBLIN, Republic of Ireland, April 23 Medtronic issued the following news release:. Medtronic plc today announced that it has received U.S. Food and Drug Administration approval for the IN.PACT (TM) Admiral (TM) Drug-Coated Balloon to treat long superficial femoral artery lesions up to 360 mm in patients with peripheral artery disease.
4/24/18 - Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions [Syrian Arab News Agency]
DUBLIN- April 23, 2018- Medtronic plc today announced that it has received U.S. Food and Drug Administration approval for the IN.PACT (TM) Admiral (TM) Drug-Coated Balloon to treat long superficial femoral artery lesions up to 360 mm in patients with peripheral artery disease. "Data from the IN.PACT Global Study demonstrate that IN.PACT Admiral DC
4/24/18 - Otsuka's JYNARQUE? (tolvaptan) Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Otsuka Pharmaceutical Co., Ltd. announces that the U.S. Food and Drug Administration has approved JYNARQUE? as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease. This press release features multimedia. These cysts enlarge the kidneys and impair their abil
4/24/18 - Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
TRUMENBA previously received Breakthrough Therapy designation in 2014 for the prevention of MenB in adolescents and young adults ages 10 through 25 years, and later the same year received FDA approval as the first MenB vaccine approved in the U.S.. Pfizer has successfully completed Phase 2 studies in this investigational age group and these data ha
4/24/18 - Quotient Limited Announces FDA Approval of Seven Blood Bank Reagents, Including Two Market Firsts
Quotient Limited, an established, commercial-stage diagnostics company, today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts. "We are very proud to be first to market with FDA approved monoclonal Anti-Fy and monoclonal Anti-C. Our new Anti-Fy and Anti-C antisera give robust
4/24/18 - Samsung Announces Commitment to Lower Dose Exposure Within its Digital Radiography Suite
Samsung has announced a growth vision centered on improving the quality and safety of patient care through a commitment to lower radiation across its innovative suite of medical imaging products. Samsung s engine S-Vue? 3.02 received FDA clearance last November for use at 50 percent dose reduction for adult chest exams. The GC85A incorporates
4/24/18 - Sandstone Diagnostics Announces FDA 510(k) Clearance and Commercial Launch of Trak Volume Cup
LIVERMORE, CALIFORNIA, US, April 24, 2018/ EINPresswire.com/ Sandstone Diagnostics, a medical device company focused on a data-driven approach to men s reproductive health, proudly announces the FDA 510 clearance and commercial launch of the Trak Volume Cup. The patent-pending Volume Cup is the first FDA- cleared device that allows men to m
4/24/18 - U.S. Food and Drug Administration Approves Opdivo + Yervoy Combination as First Line Treatment for Intermediate and Poor Risk Advanced Renal Cell Carcinoma
PRINCETON- Bristol-Myers Squibb Company today announced that Opdivo 3 mg/kg plus Yervoy 1 mg/kg was approved by the U.S. Food and Drug Administration as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma. 1,2 In the Phase 3 CheckMate -214 clinical trial, the
4/23/18 - Amerigen and Dipharma Announce U.S. FDA Approval for Generic Miglustat 100 mg Capsules
LYNDHURST, N.J. and CHIASSO, Switzerland, April 23rd, 2018/ PRNewswire/ Amerigen Pharmaceuticals Limited and Dipharma S.A. today announced that Amerigen's Abbreviated New Drug Application for Miglustat 100 mg capsules has received final approval from the U.S. Food and Drug Administration. Miglustat active ingredient is supplied to Amerigen by Dip
4/23/18 - BAUSCH + LOMB RECEIVES 510(K) CLEARANCE FROM FDA FOR BOSTON SCLERAL LENS CASE
BRIDGEWATER- Bausch+ Lomb, a leading global eye health company, today announced that the company's Specialty Vision Products business has received 510 clearance from the U.S. Food and Drug Administration for the Boston scleral lens case, a storage case developed specifically for scleral lenses. The Boston scleral lens case is indicated for use with
4/23/18 - CANbridge Receives Approval to Commence CAN008 Phase II/III Trial in Glioblastoma Multiforme GBM in China
By a News Reporter-Staff News Editor at Pharma Business Week CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the China Food and Drug Administration has approved the Investigational New Drug application for a Phase II/III clinical study of lead candidate, CA
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