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Results For "approval"

2476 News Found

Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India
News | April 19, 2022

Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India

Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer


Amneal achieves second U.S. biosimilars approval with Alymsys
Drug Approval | April 18, 2022

Amneal achieves second U.S. biosimilars approval with Alymsys

Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022


Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets
Drug Approval | April 18, 2022

Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection
Drug Approval | April 18, 2022

Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection

The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat


Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg
Drug Approval | April 15, 2022

Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg

The product will be manufactured at Lupin’s facility in Goa, India


Aleor receives USFDA approval for Lidocaine and Prilocaine Cream
Drug Approval | April 12, 2022

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA


Glenmark Specialty receives DCGI approval for Phase 1 clinical trial of its novel molecule
Biotech | April 11, 2022

Glenmark Specialty receives DCGI approval for Phase 1 clinical trial of its novel molecule

GRC 54276 has shown tumour cell killing ability in preclinical studies as a single agent and as well in combination with checkpoint inhibitors, making it a high-priority target in immuno-oncology


Alembic gets USFDA tentative approval for dabigatran etexilate capsules
Drug Approval | April 07, 2022

Alembic gets USFDA tentative approval for dabigatran etexilate capsules

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim


Gufic Biosciences receives DCGI approval for Thymosin Alpha-1 to treat Covid-19
Drug Approval | April 06, 2022

Gufic Biosciences receives DCGI approval for Thymosin Alpha-1 to treat Covid-19

Immunocin, an Immuno-modulator drug, significantly reduced the risk of death in the Phase 3 clinical trial in adult patients with moderate-to-severe Covid-19


Abott gets USFDA approval for leadless pacemaker
Drug Approval | April 05, 2022

Abott gets USFDA approval for leadless pacemaker

Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced