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 The leading web portal for pharmacy resources, news, education and careers November 21, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 21, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 246     Next >>     Go To Page:

11/13/17 - Abbott Announces FDA Clearance for its Alinity ci-series Next-generation Diagnostic Systems
By a News Reporter-Staff News Editor at Pharma Business Week Abbott has secured U.S. Food and Drug Administration 510 clearance for its Alinity? ci-series instruments for clinical chemistry and immunoassay diagnostics. "Healthcare systems across the United States are under pressure to deliver better care for patients," said Brian Blaser, execu
11/13/17 - AEGEA Medical Announces U.S. FDA Approval of the AEGEA Vapor System(TM) with Adaptive Vapor Ablation for the Treatment of Menorrhagia
AEGEA Medical, Inc., a privately held medical device company focused on the development of its patented Adaptive Vapor Ablation technology, today announced U.S. FDA approval of the AEGEA Vapor System as a new treatment option for menorrhagia. AEGEA Medical's technology utilizes the naturally expansive power of water vapor to deliver a safe, effecti
11/13/17 - Allergan Receives FDA Approval For Label Expansion Of VRAYLAR
WASHINGTON- Allergan plc announced the U.S. FDA has approved the supplemental New Drug Application for VRAYLAR for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder. The efficacy of VRAYL
11/13/17 - Allergan Receives FDA Approval For Use of VRAYLAR? (cariprazine) in the Maintenance Treatment of Schizophrenia
Allergan plc today announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application for VRAYLAR? for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I di
11/13/17 - Appili Receives FDA and Health Canada Clearance to Begin Clinical Trials of its Antibiotic Oral Liquid Reformulation
By a News Reporter-Staff News Editor at Pharma Business Week Appili Therapeutics Inc., an anti-infective drug development company, announced that both the US Food and Drug Administration and Health Canada have cleared its IND and CTA clinical investigation applications, respectively, to conduct a clinical trial of ATI-1501, a taste-masked antibio
11/13/17 - Dynavax Under Selling Pressure
Dynavax Technologies Corporation shares are trading lower by $1.95 at $18.30 in Monday's session. After last Thursday's close, the company announced it received FDA approval for Heplisav-B for the prevention of Hepatitis B in adults. Unfortunately for investors, Dynavax has been a "sell the news" scenario as the stock has nearly double since its Ju
11/13/17 - EMD Serono Receives FDA Approval for New GONAL-f RFF Redi-ject Pen
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, received approval for a redesigned version of GONAL- f RFF* Redi- ject pen injector from the U.S. Food and Drug Administration. The redesigned GONAL- f RFF Redi-ject pen is the second version since its initial approval, underscoring E
11/13/17 - FDA Approves New 10 mg Dosing for XARELTO rivaroxaban to Reduce the Continued Risk of Venous Thromboembolism VTE
By a News Reporter-Staff News Editor at Pharma Business Week Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration approved the 10 mg once-daily dose of XARELTO for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial anticoagulation therapy. This approval foll
11/13/17 - FDA approves Vraylar in the maintenance treatment of schizophrenia
The FDA has approved the supplemental New Drug Application for Vraylarfor the maintenance treatment of adults with schizophrenia...
11/13/17 - FDA Clears I.C. Medical's Advanced Surgical Smoke Evacuation System
Phoenix, AZ 11/13/2017 The U.S. Food and Drug Administration has granted Phoenix- based I.C. Medical Company 510 clearance to market the Crystal Vision 450 D in the United States on October 30, 2017. The Crystal Vision 450 D is an "intelligent" surgical smoke evacuation device, with sophisticated features and enhanced functionality. It employ
11/13/17 - Innovus Pharma Enters the $11 Billion Glucose Monitoring Market with FDA-Cleared Products via an Expanded Agreement with ACON Laboratories, Inc.
Innovus Pharmaceuticals, Inc., an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men s and women's health and respiratory diseases, today announced that it has entered into an additional agreement with current partner ACON Laboratories,
11/13/17 - Kamada Reports Financial Results for Third Quarter and First Nine Months of 2017
We were also pleased to have received the U.S. Food and Drug Administration approval in the third quarter for our Anti-Rabies IgG, KEDRAB?, and look forward to launching this product in the U.S. in collaboration with Kedrion, our strategic partner, early in 2018. With the continued growth of sales of Glassia in the U.S. and our planned launch
11/13/17 - Keryx Biopharmaceuticals - U.S. FDA Approves Auryxia Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease
BOSTON- Keryx Biopharmaceuticals, Inc., a company focused on bringing innovative medicines to people with kidney disease, today announced that the U.S. Food and Drug Administration has approved Auryxia for an additional indication. 'More than half of the approximate 30 million people in the United States living with chronic kidney disease are iron
11/13/17 - Luminex Corporation Receives FDA Clearance for ARIES Group A Strep Assay
By a News Reporter-Staff News Editor at Pharma Business Week Luminex Corporation announced that it has received FDA clearance for the ARIES Group A Strep Assay, a moderate complexity, sample to answer test for the direct detection of Streptococcus pyogenes from throat swab specimens using the ARIES System. This is the sixth assay the FDA ha
11/13/17 - Merck Receives FDA Approval for New GONAL-f(R) Prefilled Pen
New pen is easy- to- learn and easy- to- use, supporting the one in six couples affected by infertility in the U.S. Insights of p atients, nurses and doctors help ed to evolve the product. Known as GONAL- f RFF Redi-ject TM* prefilled pen in the U.S. and originally approved by the FDA in 2013, the new version of the pen is easy-to-learn and easy
11/13/17 - Merck Receives FDA Approval for New GONAL-f Prefilled Pen
New pen is easy- to- learn and easy- to- use, supporting the one in six couples affected by infertility in the U.S. Insights of p atients, nurses and doctors help ed to evolve the product. Known as GONAL- f RFF Redi-ject TM* prefilled pen in the U.S. and originally approved by the FDA in 2013, the new version of the pen is easy-to-learn and easy
11/13/17 - New Tuberculosis Study Findings Have Been Reported by Z.S. Bhat and Co-Researchers (a-pyrones and their hydroxylated analogs as promising scaffolds...
New Tuberculosis Study Findings Have Been Reported by Z.S. Bhat and Co-Researchers. By a News Reporter-Staff News Editor at AIDS Weekly Investigators publish new report on Mycobacterium Infections- Tuberculosis. In this direction, hydroxylated a-pyrone scaffold has received US FDA approval for human use against HIV.
11/13/17 - Nexstim gains FDA clearance to commercialise its NBT system in the US for the treatment of depression
Company announcement, Helsinki, 13 November 2017 at 3 pm Nexstim Plc, a medical technology company developing and marketing pioneering navigated non-invasive brain stimulation systems for both therapeutic and diagnostic applications, announces that the Food and Drug Administration has cleared Nexstim's NBT system for marketing and commercial...
11/13/17 - Novartis submits application to FDA for Kymriah tisagenlecleucel in adult patients with r/r DLBCL, seeking second indication for first-ever FDA...
Novartis submits application to FDA for Kymriah tisagenlecleucel in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy. In August 2017, Kymriah became the first available chimeric antigen receptor T cell therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for pati
11/13/17 - Perrigo Announces Tentative FDA Approval for a First-to-File Generic Version of Picato Gel 0.05%
By a News Reporter-Staff News Editor at Pharma Business Week Perrigo Company plc announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Picato Gel 0.05%. The submission date of Perrigo's Abbreviated New Drug Application matches the first-to-file date posted on FDA's Paragraph IV Paten
11/13/17 - Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study
By a News Reporter-Staff News Editor at Clinical Trials Week Second Sight Medical Products, Inc., a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, announced that the Company has received full approval from the U.S. Food and Drug Administrati
11/11/17 - BRIEF: Heron Therapeutics wins approval of cancer drug [The San Diego Union-Tribune]
Nov. 10 San Diego's Heron Therapeutics said Thursday it has received marketing approval for a drug to prevent chemotherapy-associated nausea and vomiting. The injectable drug, Cinivanti, is the second such drug for Heron Therapeutics; the first is Sustol. Cinivanti was approved by the U.S. Food and Drug Administration on the basis of clinical stu
11/11/17 - Dynavax Announces FDA Approval of First and Only Two-Dose Hepatitis B Vaccine [Arab News (Saudi Arabia)]
Dynavax Technologies announced that the U.S. Food and Drug Administration has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adu
11/11/17 - FDA OKs drug to block infection after marrow transplant [Tehran Times (Iran)]
United States regulators have approved the first drug to prevent life-threatening infections in adults after a bone marrow transplant. The Food and Drug Administration approved on Wednesday the sales of Merck and Co.s Prevymix to prevent infections with cytomegalovirus, a common virus. Merck, which is based in Kenilworth, New Jersey, said the drug
11/10/17 - FDA Approves DVAX's Hep B Vaccine, OMER Catches Eyes, It's 4 For SGEN's Adcetris
WASHINGTON- Today's Daily Dose brings you news about the strong Q3 results of Omeros, FDA approvals of hepatitis B vaccine, CINV drug and a lymphoma drug. Shares of Dynavax Technologies Corp. were up more than 15% in extended trading on Thursday, following FDA approval of HEPLISAV-B, the Company's vaccine for prevention of Hepatitis B in adults.
Articles(s): 1 - 25 of 246     Next >>     Go To Page:


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