Search For "drug administration"
FDA removes hold on clinical trial for phase 2,3 for COVAXIN-BBV152 says
Updated : 3 years, 9 months ago IST
Malvern (Pennsylvania) [US], May 23 (ANI): Biotechnology company Ocugen on Monday announced that the US Food and Drug Administration (FDA) lifted the clinical hold on the Company's Phase 2, 3 clinical trials for COVAXIN™ (BBV152).
Read More
Glenmark Pharmaceuticals receives sANDA approval for Abiraterone Acetate T
Updated : 3 years, 9 months ago IST
Mumbai (Maharashtra) [India], May 20 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc, USA (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga®1 Tablets, 500 mg, of J
Read More
NeoImmuneTech obtains approval for phase 2 trial of brain tumor treatment
Updated : 3 years, 10 months ago IST
Seoul [South Korea], May 12 (ANI/Global Economic): NeoImmuneTech said on the 11th that it has obtained the approval for a phase 2 clinical trial plan that concomitant administration of US Merck's immune checkpoint inhibitor Keytruda and its T-cell amplifier NT-I7 to patients with glioblastom
Read More
Glenmark Pharmaceuticals receives tentative ANDA approval for Calcipotrien
Updated : 3 years, 10 months ago IST
Mumbai (Maharashtra) [India], May 9 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005 per cent|0.064 per cent, the gen
Read More
US FDA limits use of Johnson & Johnson COVID-19 vaccine over blood clo
Updated : 3 years, 10 months ago IST
Washington [US], May 6 (ANI): The US Food and Drug Administration (FDA) on Thursday said that the Johnson & Johnson vaccine that has been administered to more than 18 million Americans can potentially cause "life-threatening blood clots", and thereby warranted "limiting the authorized us
Read More
FDA authorizes first-ever breathing test for detecting COVID-19 infection
Updated : 3 years, 11 months ago IST
Washington [US], April 16 (ANI): The Food and Drug Administration (FDA) authorized the first test, InspectIR COVID-19 Breathalyzer, to detect COVID-19 through the breath for emergency use.
Read More
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
Read More
Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets USP
Updated : 3 years, 11 months 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&
Read More
Moderna requests FDA to authorize second COVID-19 booster shot for adults
Updated : 3 years, 12 months 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
Read More
Zydus receives final approval from USFDA to market Colestipol Hydrochlorid
Updated : 4 years ago IST
Ahmedabad (Gujarat) [India], March 15 (ANI): Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid), said the pharmaceutical company on Monday.
Read More
Zydus receives final approval from USFDA to market drug used to relieve ch
Updated : 4 years ago IST
New Delhi [India], March 9 (ANI): Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Nitroglycerin Sublingual tablets used to relieve chest pain in people who have certain heart conditions, said the pharmaceutical company
Read More
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).
Read More