Search For "fda"
FDA grants Direct Biologics regenerative Medicine Advanced Therapy (RMAT)
Updated : 3 years, 11 months ago IST
Austin (Texas) [US], April 13 (ANI/PRNewswire): Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenera
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Sanrai Med India bullish on bringing 'Hospital Grade Care at Home' through
Updated : 3 years, 11 months ago IST
Chandigarh [India], April 7 (ANI/PNN): Sanrai Med India, a leading provider of innovative, reliable, and FDA approved medical equipment and devices for patients in India, is all set to provide 'Hospital Grade Care at Home' to Indian patients through its 'Sanrai Solutions' offering.
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Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets USP
Updated : 4 years ago IST
Mumbai (Maharashtra) [India], March 21 (ANI/PR Newswire): Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Tablets1 USP, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat&
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Moderna requests FDA to authorize second COVID-19 booster shot for adults
Updated : 4 years ago IST
Washington [US], March 18 (ANI/Xinhua): American biotechnology company Moderna submitted a request to the U.S. Food and Drug Administration (FDA) on Thursday for emergency use authorization (EUA) on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older, who already recei
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COVID-19: FDA gives clearance to Covaxin for clinical trials in adults in
Updated : 4 years ago IST
New Delhi [India], March 7 (ANI): Bharat Biotech's COVID-19 vaccine Covaxin has been given clearance for clinical trials in adults by the US Food and Drug Administration (FDA).
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India to Look Younger as Leading American Brand 7e Wellness launches first
Updated : 4 years ago IST
Mumbai (Maharashtra) [India], March 2 (ANI/BusinessWire India): With microcurrent facials sparking conversations across the globe around anti-ageing and stimulating facial collagen, America's FDA-cleared, non-invasive microcurrent devices by 7e Wellness are coming to India, all set to throng
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US FDA clinical study proves non-contact thermometers fail to meet accurac
Updated : 4 years, 1 month ago IST
Watertown (Massachusetts) [US], February 15 (ANI/BusinessWire India): Since the start of the pandemic, non-contact infrared thermometers (NCITs) have been widely used as a screening method for fever detection in healthcare and public settings, as fever is a leading sign of COVID-19. Now, a n
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US FDA grants the coveted Breakthrough Designation for early-stage prostat
Updated : 4 years, 1 month ago IST
Mumbai (Maharashtra) [India], February 15 (ANI/PR Newswire): Datar Cancer Genetics today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Designation' for its blood test to detect early-stage prostate cancer. This is the second test from the Company that has
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Moderna's 'Spikevax' COVID19 vaccine gets full approval by FDA
Updated : 4 years, 1 month 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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Philippines FDA approves world's first generic version of Pfizer's anti-Co
Updated : 4 years, 1 month ago IST
Manila [Philippines], January 26 (ANI/PNN): The Philippines Food and Drug Administration (FDA) has approved the world's first generic version of Pfizer's anti-Coronavirus pill Paxlovid, just days after the original was granted Emergency Use Authorisation (EUA) by the US FDA.
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Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson
Updated : 4 years, 2 months ago IST
Mumbai (Maharashtra) [India], January 17 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the g
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Glenmark's subsidiary receives NDA Approval by US FDA for Ryaltris™
Updated : 4 years, 2 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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