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Tag: usfda

You Searched For "usfda"
COVID-19: US CDC director signs recommendation to use Pfizer-BioNTech vax

COVID-19: US CDC director signs recommendation to use Pfizer-BioNTech vax

MD Bureau14 Dec 2020 12:15 PM IST
Washington: Director of the US Centers for Disease Control and Prevention (CDC) Robert Redfield said he has signed the recommendation of a key CDC...
Germany BioNTech CEO looks for more vaccine production

Germany BioNTech CEO looks for more vaccine production

Ruchika Sharma13 Dec 2020 9:30 AM IST
New York: The chief executive of Germany's BioNTech SE said the biggest challenge facing it and partner Pfizer Inc now that their Covid-19 vaccine is...
Pfizer bags USFDA emergency use approval for COVID-19 vaccine

Pfizer bags USFDA emergency use approval for COVID-19 vaccine

MD Bureau12 Dec 2020 2:30 PM IST
Pfizer said its overall vaccine efficacy of 95 percent was observed in both younger and older adults as well as diverse demographics.
Alembic Pharma gets USFDA nod for Asenapine Sublingual Tablets to treat bipolar disorder

Alembic Pharma gets USFDA nod for Asenapine Sublingual Tablets to treat bipolar disorder

Ruchika Sharma12 Dec 2020 11:39 AM IST
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.
Pfizer gets USFDA priority review for 20-valent pneumococcal conjugate vaccine

Pfizer gets USFDA priority review for 20-valent pneumococcal conjugate vaccine

Ruchika Sharma11 Dec 2020 2:59 PM IST
New York: Pfizer Inc. has recently announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License...
Zydus Cadila Saroglitazar secures USFDA Fast Track Designation to treat Primary Biliary Cholangitis

Zydus Cadila Saroglitazar secures USFDA Fast Track Designation to treat Primary Biliary Cholangitis

Ruchika Sharma10 Dec 2020 12:27 PM IST
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that United States Food and Drug Administration (USFDA) has granted "Fast Track...
Pfizer Covid vaccine shows favourable safety profile, says USFDA

Pfizer Covid vaccine shows favourable safety profile, says USFDA

MD Bureau10 Dec 2020 9:00 AM IST
New York: Raising hope of granting emergency use authorisation to drugmakers Pfizer and BioNTech's experimental Covid-19 vaccine, the US Food and Drug...
Aurobindo Pharma gets USFDA nod for Dexmedetomidine HCL in 0.9% Sodium Chloride Injection

Aurobindo Pharma gets USFDA nod for Dexmedetomidine HCL in 0.9% Sodium Chloride Injection

Ruchika Sharma9 Dec 2020 12:59 PM IST
Hyderabad: Pharma major, Aurobindo Pharma Limited, today announced that the company has received final approval from the US Food & Drug...
Janssen Pharma seeks USFDA nod for Amivantamab for treating metastatic non-small cell lung cancer

Janssen Pharma seeks USFDA nod for Amivantamab for treating metastatic non-small cell lung cancer

Ruchika Sharma6 Dec 2020 10:00 AM IST
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S....
Alembic Pharma Metolazone Tablets get USFDA nod

Alembic Pharma Metolazone Tablets get USFDA nod

Ruchika Sharma4 Dec 2020 1:00 PM IST
Metolazone Tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
Eli Lilly to supply 650,000 additional Covid doses to US Govt

Eli Lilly to supply 650,000 additional Covid doses to US Govt

Ruchika Sharma4 Dec 2020 10:00 AM IST
New Delhi: Eli Lilly and Co said on Wednesday the U.S. government has purchased 650,000 additional doses of its Covid-19 antibody drug for $812.5...
Alembic Pharma associate firm gets USFDA nod for trial on retroviral oral drug for COVID treatment

Alembic Pharma associate firm gets USFDA nod for trial on retroviral oral drug for COVID treatment

MD Bureau3 Dec 2020 2:19 PM IST
New Delhi: Rhizen Pharmaceuticals, an associate company of Alembic Pharmaceuticals, on Wednesday said it has received approval from the US health...
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