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Results For "approval"

2612 News Found

Zydus Cadila receives approval for glycopyrrolate injection
Drug Approval | November 10, 2021

Zydus Cadila receives approval for glycopyrrolate injection

Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated


Novavax files for approval of its Covid-19 vaccine in the UK
Biotech | October 27, 2021

Novavax files for approval of its Covid-19 vaccine in the UK

Filing marks first protein-based vaccine submitted to MHRA for authorization


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


IOL receives Korean FDA approval
Drug Approval | October 14, 2021

IOL receives Korean FDA approval

The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead


Covaxin for kids gets nod, final approval awaited
Drug Approval | October 12, 2021

Covaxin for kids gets nod, final approval awaited

The two doses of Covaxin are likely to be administered to children with a gap of 28 days


Lincoln Pharma gets Australian TGA approval
News | October 08, 2021

Lincoln Pharma gets Australian TGA approval

The company plans to expand its portfolio in regulated markets aggressively


WHO decision on Covaxin approval next week
Drug Approval | October 06, 2021

WHO decision on Covaxin approval next week

Bharat Biotech has been submitting data to the WHO on a rolling basis and submitted additional information at WHO’s request on September 27th 2021


Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India