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Results For "approval"

2474 News Found

Concept Medical gets 4th IDE approval from USFDA
Drug Approval | May 31, 2023

Concept Medical gets 4th IDE approval from USFDA

For the treatment of Superficial Femoral Artery


Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection
Drug Approval | May 27, 2023

Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection

The product is expected to be launched in June 2023


Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection
Drug Approval | May 22, 2023

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States


Granules India received ANDA approval for Venlafaxine ER capsules
Drug Approval | May 20, 2023

Granules India received ANDA approval for Venlafaxine ER capsules

Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder


Farxiga’s expanded approval highlights potential to differentiate in HF space, says GlobalData
News | May 17, 2023

Farxiga’s expanded approval highlights potential to differentiate in HF space, says GlobalData

Farxiga is expected to have such a strong influence on the market due to the impressive results


Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq
Drug Approval | May 10, 2023

Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq

The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region


Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment
Drug Approval | May 03, 2023

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma


Zydus receives final approval from the USFDA for Metronidazole Topical Cream
Drug Approval | April 25, 2023

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea