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Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book

Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book
ipwatchdog.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from ipwatchdog.com Daily Mail and Mail on Sunday newspapers.

United statesNew jerseyTeva proairDrug administrationUnited states district courtDistrict court verdictInhaler patentsOrange bookNew drug applicationFederal trade commissionHatch waxman actAbbreviated new drug applicationDismiss amnealPartial judgement

FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC

The accelerated approval is based on data from the phase 3 ELATIVE trial demonstrating a reduction in alkaline phosphatase with elafibranor.

United kingdomUnited statesKris kowdleyChristelle huguetIpsen iqirvoLiver instituteHealthcare products regulatory authorityDrug administrationEuropean medicines agencyAmerican associationLiver diseaseLiver institute northwestEuropean associationUnited kingdom medicinesHealthcare products regulatoryBreakthrough therapy designation

Osimertinib Gets Priority Review for Stage III Unresectable EGFR-Mutated NSCLC

The sNDA is supported by data from the phase 3 LAURA trial.

Drug administrationPriority reviewNew drug application

Tonix Pharmaceuticals Announces Proposed Public Offering

Tonix Pharmaceuticals Announces Proposed Public Offering
globenewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from globenewswire.com Daily Mail and Mail on Sunday newspapers.

Jessica morrisBoca ratonZembrace symtouchPeter vozzoTonix pharmaceuticalsExchange commissionTonix pharmaceuticals holding corpDrug administrationDawson james securities incPharmaceuticals holdingJames securitiesDawson james securitiesFederal highwayNew drug applicationBreakthrough therapyPrivate securities litigation reform act

New Drug Application (NDA) Submissions 505(b)(1) Or 505(b)(2)

There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough.

Drug administrationPropharma groupAppropriate regulatoryNew chemical entityNew drug applicationAbbreviated new drug applicationReference listed drugElectronic common technical document

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