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Tag: usfda

You Searched For "usfda"
USFDA to soon authorize Pfizer COVID booster shot for children aged 5 to 11: NYT

USFDA to soon authorize Pfizer COVID booster shot for children aged 5 to 11: NYT

Ruchika Sharma17 May 2022 11:00 AM IST
They have cited data from a mid- to late-stage study showing a third dose of their shot increased protection against the original coronavirus version...
Glenmark, Dr Reddys and 2 others recall products in US

Glenmark, Dr Reddys and 2 others recall products in US

Ruchika Sharma16 May 2022 2:19 PM IST
New Delhi: Homegrown drug majors Lupin, Glenmark and Dr Reddy's Laboratories are recalling different products in the US, the world's largest market...
Novel novel mesh plug effective for treatment of sidewall brain aneurysm

Novel novel mesh plug effective for treatment of sidewall brain aneurysm

Dr. Kamal Kant Kohli15 May 2022 9:30 PM IST
OAK BROOK: A novel mesh plug that has been traditionally used to treat brain aneurysms occurring where the blood vessels branch out was found to be...
Moderna concludes USFDA submission for use of COVID vaccine in adolescents, kids

Moderna concludes USFDA submission for use of COVID vaccine in adolescents, kids

Ruchika Sharma15 May 2022 9:30 AM IST
New Delhi: Moderna Inc has made all necessary submissions required by the U.S. Food & Drug Administration for emergency use authorization of its...
Eli Lilly Mounjaro injection gets USFDA nod for type 2 diabetes

Eli Lilly Mounjaro injection gets USFDA nod for type 2 diabetes

Ruchika Sharma14 May 2022 3:17 PM IST
Mounjaro will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and will come in Lilly's auto-injector pen with a pre-attached,...
USFDA nod to Eli Lilly Olumiant for certain hospitalized Covid patients

USFDA nod to Eli Lilly Olumiant for certain hospitalized Covid patients

Ruchika Sharma13 May 2022 1:02 PM IST
OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly.
Sun Pharma bags USFDA nod for generic Mesalamine ER capsules to treat bowel disease

Sun Pharma bags USFDA nod for generic Mesalamine ER capsules to treat bowel disease

Ruchika Sharma13 May 2022 11:49 AM IST
Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has recently announced that the company has received final approval from US Food and Drug...
Oman to fast-track nod of USFDA registered Indian pharma products

Oman to fast-track nod of USFDA registered Indian pharma products

Ruchika Sharma12 May 2022 10:00 AM IST
"We expect that with the fast tracking of registration of Indian pharma products, we can significantly gain in the Omani pharma market which is...
Alembic Pharma bags USFDA nod for Arformoterol Tartrate Inhalation Solution

Alembic Pharma bags USFDA nod for Arformoterol Tartrate Inhalation Solution

Ruchika Sharma11 May 2022 1:24 PM IST
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited.
USFDA issues 6 observations after inspection of Aurobindo Pharmas Jedcherla facility

USFDA issues 6 observations after inspection of Aurobindo Pharma's Jedcherla facility

Ruchika Sharma11 May 2022 12:59 PM IST
"The Company will respond to the USFDA within the stipulated timeline and work closely with USFDA to close the observations," the company added.
Sun Pharma gets 10 USFDA observations for Halol facility

Sun Pharma gets 10 USFDA observations for Halol facility

Ruchika Sharma10 May 2022 1:04 PM IST
Mumbai: Pharma major, Sun Pharma, today announced that US Food and Drug Administration (USFDA) has recently concluded the Good Manufacturing...
Glenmark Pharma bags USFDA nod for generic version of Enstilar Foam

Glenmark Pharma bags USFDA nod for generic version of Enstilar Foam

Ruchika Sharma9 May 2022 11:00 AM IST
Mumbai: Drugmaker, Glenmark Pharmaceuticals Inc., USA, today announced that it has received tentative approval from the United States Food & Drug...
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