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 The leading web portal for pharmacy resources, news, education and careers March 29, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 29, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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3/24/17 - FDA Approves Treatment for Metastatic Merkel Cell Carcinoma
The US Food and Drug Administration has granted accelerated approval for Bavencio (avenulab), a treatment for a rare and aggressive form of skin cancer called metastatic Merkel cell carcinoma (MCC).
3/24/17 - FDA Grants Approval for BAVENCIO (avelumab)
Release date- 23032017- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announce that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use. Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US. Immuno-onco
3/24/17 - FDA Grants Approval for BAVENCIO (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Release date- 23032017- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merke
3/24/17 - Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine
Release date- 23032017- WINNIPEG- Medicure Inc., a leading Canadian specialty pharmaceutical company, is pleased to announce that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug application for tetrabenazine tablets in the 12.5 mg and 25 mg st
3/24/17 - Merck KGaA : FDA Approves First Treatment For Rare Form Of Skin Cancer
NEW YORK CITY- Merck KgaA and Pfizer Inc. announced that the US Food and Drug Administration has approved BAVENCIO or avelumab Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma or mMCC. BAVENCIO will be co-commercialized by EMD Serono, the biopharmace
3/24/17 - Surgery Without the Knife: Mirabilis Medical Announces European Approval for Non-Invasive Uterine Fibroid Treatment
Mirabilis Medical, a Seattle- area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union. The company simultaneously announced that it had received approval from the US Food and Drug Administrati
3/24/17 - Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Gel, 0.05%
By a News Reporter-Staff News Editor at Drug Week Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, announced it has received approval of the Company's abbreviated new drug application from the U.S. Food and Drug Administration of Clobetasol Propionate Gel, 0.05%. This is Teligent's second approval for 2017, and its th
3/23/17 - Alcon Announces FDA Approval For AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL
BASEL- Alcon, a division of Novartis, announced it has received approval from the US FDA for its AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ACTIVEFOCUS optical design for patients undergoing cataract surgery who choose to address their astigmatism and presbyopia at the same time. Alcon plans to commercialize the ACTIVEFOCUS toric
3/23/17 - Alcon Receives US FDA Approval for New AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with Activefocus Design for Uncompromised Distance Vision and...
BASEL, Switzerland, March 23 Novartis issued the following news release:. Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration for its AcrySof (R) IQ ReSTOR (R) +2.5 Multifocal Toric intraocular lens with ACTIVEFOCUS (TM) optical design for patients undergoing cataract sur
3/23/17 - Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction
Novartis International AG/ Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS (TM) design for uncompromised distance vision and presbyopia correction. *The unique optical design of the ACTIVEFOCUS toric IOL gives astigmatic cataract patients quality distance vision and an increased range of vis
3/23/17 - Blood Bank: FDA audit clears whistleblower assertions in areas it regulates. But a key allegation was not addressed. [Alaska Dispatch News, Anchorage]
Bob Scanlon, CEO at Blood Bank of Alaska, said on Wednesday the detailed FDA audit and investigation cleared the blood bank of all allegations in areas the FDA oversees, including assertions the bank was overdrawing blood from donors. A copy of the FDA report was not available. The FDA does not specify a minimum inventory of blood BBA or other bloo
3/23/17 - FDA Approves First Treatment for Rare Form of Skin Cancer
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. This is the first FDA- approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. "While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved t
3/23/17 - FDA Approves NanoCoated Coronary Stent System Using DSG's eClinical Systems
CeloNova Biosciences, Inc., leveraging products and services provided by DSG, Inc., a leading eClinical software technology and data management global services firm, recently received US Food and Drug Administration approval of its first-in-class COBRA PzF? NanoCoated Coronary Stent System. There continues to be an unmet clinical need for pati
3/23/17 - FDA Grants Approval for BAVENCIO (avelumab)
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announce that the US Food and Drug Administration has approved BAVENCIO (R) Injection 20 mg/mL, for intravenous use. Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US. Immuno-oncology is a top priori
3/23/17 - FDA Grants Approval for BAVENCIO (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Pfizer, a pharmaceutical company, issued the following news release:. EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO (R) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric
3/23/17 - FDA Grants Approval for BAVENCIO (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Merck and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma. Continued approval for this indication may be contingent upon verification and description of cl
3/23/17 - Federal audit clears Blood Bank whistleblower assertions. But a key charge wasn't addressed. [Alaska Dispatch News, Anchorage]
Bob Scanlon, CEO at Blood Bank of Alaska, said on Wednesday the detailed FDA audit and investigation cleared the blood bank of all allegations in areas the FDA oversees, including assertions the bank was overdrawing blood from donors. A copy of the FDA report was not available. The FDA does not specify a minimum inventory of blood BBA or other bloo
3/23/17 - Further milestone for JUVORA dental disc: US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics
Release date- 22032017- A major innovation in dental prosthetics for comfort, durability and precision, the JUVORA dental disc, has received the US Food and Drug Administration 510 clearance for expanded indications. Following its successful CE mark approval in Europe and introduction onto the European dental market in 2012, the JUVORA dental disc
3/23/17 - GNW-News: Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction (english)
Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS (TM) design for uncompromised distance vision and presbyopia correction. Novartis International AG/ Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS (TM) design for uncompromised distance
3/23/17 - Lupin receives FDA approval for generic TOBI inhalation solution [India Infoline News Service]
Pharma Major Lupin Limited announced today that it has received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from the United States Food and Drug Administration to market a generic version of Novartis Pharmaceuticals Corporation's TOBI 300 mg/5 ml. Pharma Major Lupin Limited announced today that it has received final appro
3/23/17 - Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine
-Medicure Inc., a leading Canadian specialty pharmaceutical company, is pleased to announce that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug application for tetrabenazine tablets in the 12.5 mg and 25 mg strengths. Medicure currently owns.
3/23/17 - Medtronic plc. Ordinary Shares (NYSE:MDT) Corevalve Evolut PRO System Wins FDA Approval
The CoreValve Evolut Pro, a device developed by Medtronic plc. Ordinary Shares (NYSE:MDT) to treat patients suffering from severe aortic stenosis and who are too frail to undergo open-heart surgery. Evolut PRO is based on Medtronic's CoreValve Evolut R System and comes with a valve design that is unique as it possesses an outer wrap [?] The pos
3/23/17 - Medtronic Receives FDA Approval for CoreValve Evolut Pro Transcatheter Valve with Advanced Sealing
Release date- 22032017- DUBLIN- Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. 'Based on my experience implanting the Evolut PRO valve during the cli
3/23/17 - Medtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing [Algeria Press Service]
DUBLIN- March 22, 2017- Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. launch of the CoreValve (TM) Evolut (TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30- day clinical data that wa
3/23/17 - Ribociclib (LEE011) Receives Regulatory Approval in U.S. as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer with an aromatase inhibitor
Release date- 22032017- Collaborative research between Otsuka's U.K. subsidiary Astex Pharmaceuticals and Novartis, which developed ribociclib and will market it. Otsuka Pharmaceutical Co., Ltd is pleased to announce that the U.S. FDA has granted regulatory approval to Novartis for ribociclib, on which Otsuka's Cambridge-U.K. based subsidiary Astex
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