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Results For "approval"

2623 News Found

FDA approves Roche’s Evrysdi for use in babies under two months with SMA
Drug Approval | June 01, 2022

FDA approves Roche’s Evrysdi for use in babies under two months with SMA

Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


Glenmark Pharma reports revenue growth of 5.6% YoY in Q4
News | May 30, 2022

Glenmark Pharma reports revenue growth of 5.6% YoY in Q4

Glenmark Pharmaceuticals announced its financial results for the fourth quarter ended March 31, 2022


Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs


USFDA approves two Opdivo-based regimens
Biotech | May 29, 2022

USFDA approves two Opdivo-based regimens

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers


USFDA approves Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile


Lancet publishes results of Phase 3 programmes of Rinvoq in Ulcerative Colitis
Biotech | May 27, 2022

Lancet publishes results of Phase 3 programmes of Rinvoq in Ulcerative Colitis

Data from the three studies formed the basis of the company's application for approval by regulatory agencies


Sun Pharma acquires Uractiv portfolio from Fiterman Pharma in Romania
News | May 27, 2022

Sun Pharma acquires Uractiv portfolio from Fiterman Pharma in Romania

The acquisition is subject to customary closing conditions and necessary regulatory approvals. The financial terms of the transaction are confidential


USFDA approves Omeprazole capsules to prevent heartburn
Drug Approval | May 27, 2022

USFDA approves Omeprazole capsules to prevent heartburn

Perrigo expects to launch Omeprazole Minis later this year


Biocon - Generics & research grow; biosimilar stagnates - ICICI Securities
News | May 26, 2022

Biocon - Generics & research grow; biosimilar stagnates - ICICI Securities

ICICI Direct expects revenue CAGR of 35.6% over FY22-FY24E mainly due to the consolidation of Viatris business and they expect EBITDA margin expansion of 230bps and earnings CAGR of 64.8% over FY22-FY24E