Search For "us fda"
US FDA plans to give Moderna authorisation for emergency use
Updated : 5 years, 3 months ago IST
Washington [US], December 18 (ANI): Advisors to the US Food and Drug Administration (FDA) voted in favour to recommend that the agency must give Emergency Use Authorisation (EUA) to Moderna's COVID-19 vaccine.
Read More
US FDA authorizes Pfizer's COVID-19 vaccine for emergency use
Updated : 5 years, 3 months ago IST
New York [US], December 12 (ANI): The US Food and Drug Administration authorized Pfizer's Covid-19 vaccine for emergency use on Friday for the prevention of coronavirus disease in individuals 16 years of age and older.
Read More
FDA panel nod to emergency use approval for Pfizer vaccine
Updated : 5 years, 3 months ago IST
Washington [US], December 11 (ANI): A panel of experts advising the US Food and Drug Administration (FDA) on Thursday recommended emergency approval for the Pfizer-BioNTech Covid-19 vaccine.
Read More
Pfizer, BioNTech to submit to FDA for emergency use authorisation for thei
Updated : 5 years, 4 months ago IST
Washington [US], November 20 (ANI): American drug giant Pfizer and German laboratory BioNTech on Friday said that they will be submitting to the US Food and Drug Administration for emergency use authorisation for their COVID-19 vaccine candidate.
Read More
US FDA approves remdesivir, first drug to treat COVID-19 patients
Updated : 5 years, 5 months ago IST
Washington [US], October 23 (ANI): The United States Food and Drug Administration (FDA) has approved Remdesivir for the treatment of coronavirus, Al Jazeera reported citing a statement issued by Gilead Sciences, Inc.
Read More
Glenmark Pharmaceuticals receives ANDA approval for Sirolimus tablets, 0.5
Updated : 5 years, 5 months ago IST
Mumbai (Maharashtra) [India], Oct 19 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc, USA (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune®1 Tablets, 0.5 mg, 1
Read More
Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Dela
Updated : 5 years, 5 months ago IST
Mumbai (Maharashtra) [India] October 7 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, the generic version of Tecfide
Read More
AliveCor brings the world's only six-lead, FDA-cleared personal ECG to Ind
Updated : 5 years, 6 months ago IST
New Delhi [India] September 25 (ANI/NewsVoir): AliveCor, the global leader in US FDA-cleared personal electrocardiogram (ECG) technology, today announced its entry in the Indian market with the revolutionary launch of the most clinically-validated personal ECG device, KardiaMobile 6L.
Read More
Bengaluru organisation gets US FDA, EU nod for device that can kill COVID-
Updated : 5 years, 7 months ago IST
Bengaluru (Karnataka) [India], Aug 2 (ANI): Bengaluru based Centre for Advanced Research and Development (CARD), the research wing of organisation De scalene has come up with a device called "SHYCOCAN" (Scalene Hypercharge Corona Canon) which neutralizes the coronavirus.
Read More
Indian pharma compliance standards improving, regulatory risks here to sta
Updated : 5 years, 8 months ago IST
Mumbai (Maharashtra) [India], July 7 (ANI): Indian pharmaceutical companies have built a strong abbreviated new drug application (ANDA) pipeline since FY12 through scaling-up of investments in R&D but this will increase the inspection intensity, India Ratings and Research (Ind-Ra) said o
Read More
US FDA revokes emergency authorisation for HCQ championed by President Tru
Updated : 5 years, 9 months ago IST
Washington D.C. [US], June 15 (ANI): The US Food and Drug Administration (FDA) on Monday revoked the emergency use authorization for malaria drug hydroxychloroquine (HCQ) as a treatment for COVID-19, the use of which has been championed by President Donald Trump.
Read More
COVID-19: Cipla enters into licensing pact with Gilead to manufacture and
Updated : 5 years, 10 months ago IST
Mumbai (Maharashtra) [India], May 13 (ANI): Pharmaceutical major Cipla said on Wednesday it has signed a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distributing investigational medicine Remdesivir which has been issued an emergency use authorisation by t
Read More