Search For "fda approval"
Biocon Biologics gets U.S. FDA approval for biosimilar aflibercept Yesafil
Updated : 2 years ago IST
Biocon Biologics announced that the U.S. Food and Drug Administration (US FDA) has approved the company's application for YESAFILI, the company informed the exchange in a filing.
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Medtronic Launches Symplicity Blood Pressure Procedure - a New Horizon in
Updated : 2 years, 5 months ago IST
Mumbai (Maharashtra) [India], December 22: India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE: MDT), announced the launch of the Symplicity™ Spyral renal denervation system (RDN) for treating high blood pressure. RDN is a minimally invasive therapy that t
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Lyrus Receives US FDA Approval for Critical UTI Treatment in the US
Updated : 2 years, 5 months ago IST
Bengaluru (Karnataka) [India], December 15: The U.S. Food and Drug Administration (FDA) has approved Lyrus Life Sciences's Abbreviated New Drug Application (ANDA) for 'Methenamine Hippurate Tablets USP, 1 gram', an AB-rated, substitutable generic version of Hiprex® from Validus Pharmace
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Vaccine Partner Valneva receives FDA approval for the World's first chikun
Updated : 2 years, 6 months ago IST
Nottingham [England], November 22: The FDA on 10th November 2023 announced the approval of IXCHIQ®, Valneva's vaccine against the chikungunya virus. Notably, this is the first vaccine against the mosquito-borne disease to have been granted marketing approval by the FDA.
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MedAlliance enrolls first US patient into its third FDA IDE Study: SFA SEL
Updated : 3 years, 1 month ago IST
Geneva [Switzerland], May 5 (ANI/PRNewswire): The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLR™ in the treatment of occlusive disease of the superficial
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Ajinomoto Bio-Pharma Services receives FDA approval for High Potency Fill
Updated : 3 years, 1 month ago IST
San Diego (California) [US], April 19 (ANI/PRNewswire): Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States Food and Drug Administration (FDA) has approved the
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MedAlliance leads US Sirolimus DEB race: First US Patient enrolled into SE
Updated : 3 years, 4 months ago IST
Geneva [Switzerland], January 26 (ANI/PRNewswire): The first US patient has been enrolled at MedStar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US i
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Granules gets US drug regulator's nod for Amphetamine capsules
Updated : 3 years, 4 months ago IST
The product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.
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Research: How various cancer cells react to drug-delivery nanoparticles
Updated : 3 years, 10 months ago IST
Boston [US], July 22 (ANI): Using nanoparticles to deliver cancer drugs allows for high drug concentrations to be delivered to tumours while avoiding the harmful side effects associated with chemotherapy. However, only a few nanoparticle-based cancer drugs have received FDA approval.
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Moderna's 'Spikevax' COVID19 vaccine gets full approval by FDA
Updated : 4 years, 4 months ago IST
Washington [US], February 1 (ANI): Moderna's COVID-19 vaccine 'Spikevax' received full approval from the U.S. Food and Drug Administration (FDA), after more than a year of its "emergency use authorization", reported USA TODAY.
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Glenmark's subsidiary receives NDA Approval by US FDA for Ryaltris™
Updated : 4 years, 4 months ago IST
Mumbai (Maharashtra) [India], January 14 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received FDA approval on its New Drug Application (NDA) fo
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White House says US will have enough vaccine for all Americans by end of n
Updated : 5 years, 2 months ago IST
Washington [US], April 6, (ANI): The United States will still have enough vaccines for all Americans by the end of next month, despite problems with a single batch of "drug product" resulting in the loss of 15 million doses of Johnson & Johnson's vaccine, the White House said on Monday.
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