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MAA
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BMS Received Breakthrough Therapy Designation for Its Investigational DCV Dual Regimen
Feb 26, 2014Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
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CHMP Adopted a Positive Opinion on FINOX Biotech's MAA for BEMFOLA
Feb 7, 2014The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on FINOX Biotech's marketing authorisation application (MAA) for BEMFOLA (follitropin alfa solution for injection in ...
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MOVPE Growth of AlGaAs on GaAs Is Limited by Lattice Mismatch
Dec 20, 2013It is known that metal-organic vapor phase epitaxy (MOVPE) growth of AlGaAs on GaAs is limited by lattice mismatch at room temperature and not at growth temperature (A. Maassdorf et.al., J. Cryst. Growth 370 (2013) 150-153), notes in-situ ...
Tags: Laser Structures, Electronics
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Boehringer Ingelheim Has Submitted European Marketing Authorization Applications
Nov 15, 2013Boehringer Ingelheim has submitted European marketing authorization applications (MAA) to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over. The MAA is based on results ...
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Baxter Has Submitted a Marketing Authorization Application to The EMA
Nov 4, 2013Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B. ...
Tags: Baxter, European Medicines Agency
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Janssen-Cilag Has Submitted MAA to EMA
Nov 1, 2013Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
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GSK Has Submitted a MAA to The EMA for Its Cervical Cancer Vaccine
Aug 9, 2013British drugmaker GlaxoSmithKline (GSK) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, ...
Tags: Cervarix, Schedule Application
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EMA Accepted Eli Lilly and Boehringer Ingelheim's MAA for a Glargine Product
Jul 10, 2013The European Medicines Agency (EMA) has accepted Eli Lilly and Company and Boehringer Ingelheim's marketing authorisation application (MAA) for a new insulin glargine product, LY2963016, for review. The application has been filed through ...
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Sanlam Mulls to Acquire a 40% Holding in MCIS Zurich Insurance, to Boost Its Presence
Jun 13, 2013South Africa-based financial services provider Sanlam is mulling to acquire a 40% holding in MCIS Zurich Insurance, in an effort to boost its presence in Malaysia. People familiar with the matter were reported by thesundaily as saying ...
Tags: Sanlam Mulls, Insurance
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Aleddra Announces That Energy-Efficient EasiRetrofit® LED T8 Tube Booked Record Sales
May 3, 2013Aleddra LED Lighting, a business unit of Lightel Technologies, Inc., today announces that at Light Fair 2103 its energy-efficient EasiRetrofit® LED T8 tube booked record sales and its new LightFly™ 5000 Balloon Light drew ...
Tags: HID lamp, Light, LED Lighting
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Eisai Laboratorios Has Submitted a Marketing Authorization Application for Belviq
Apr 3, 2013Eisai's subsidiary Eisai Laboratorios has submitted a marketing authorization application (MAA) for Belviq (lorcaserin HCl) with the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. Arena Pharmaceuticals's ...
Tags: Eisai, Mexican Marketing, Belviq
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EMA Has Accepted Shionogi's MAA for Ospemifene.
Mar 29, 2013The European Medicines Agency (EMA) has accepted Shionogi's marketing authorisation application (MAA) for ospemifene. Ospemifene is developed as as vulvar and vaginal atrophy (VVA) therapy in post-menopausal women. Shionogi CEO Takashi ...
Tags: EMA, Medicines, ospemifene
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The EMA Committee for CHMP Has Adopted a Positive Opinion
Mar 27, 2013The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild. The once-daily, single tablet regimen ...
Tags: Stribild drug, Medicines, Medicine
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Takeda Pharmaceutical Company Has Submitted MAA Seeking Approval From The EMA
Mar 11, 2013Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults ...
Tags: Takeda, IBD Disease Drug, MAA, EMA
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GlaxoSmithKline and Theravance Have Announced The MAA Submission for Anoro
Jan 11, 2013GlaxoSmithKline and Theravance have announced the MAA submission for Anoro in Europe for patients with chronic obstructive pulmonary disease (COPD). The COPD therapy, administered using the ELLIPTA inhaler, is a combination of GSK573719 ...
Tags: GlaxoSmithKline, COPD therapy, chronic obstructive pulmonary disease
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