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Results For "approval"

2612 News Found

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


CanSinoBIO's Covid-19 mRNA vaccine receives clinical trial approval in China
Biotech | April 04, 2022

CanSinoBIO's Covid-19 mRNA vaccine receives clinical trial approval in China

CanSinoBIO will continue to focus on developing a variety of innovative preventive vaccines in its diversified product pipeline with proprietary technologies, including the inhaled version of its COVID-19 vaccine, Convidecia


Dysval gets regulatory approval in Japan
Drug Approval | March 29, 2022

Dysval gets regulatory approval in Japan

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients


CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma
News | March 25, 2022

CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma

Recommendation is based on pivotal data from the phase III POLARIX study


Lupin receives approval from USFDA for Sildenafil for Oral Suspension
Drug Approval | March 24, 2022

Lupin receives approval from USFDA for Sildenafil for Oral Suspension

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