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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
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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 Kingdom , United States , Kris Kowdley , Christelle Huguet , Ipsen Iqirvo , Liver Institute , Healthcare Products Regulatory Authority , Drug Administration , European Medicines Agency , American Association , Liver Disease , Liver Institute Northwest , European Association , United Kingdom Medicines , Healthcare Products Regulatory , Breakthrough Therapy Designation , New Drug Application , Prescription Drug User Fee Act , New England Journal , Elafibranor Slows Disease Progression , Improves Itch Related Qol ,

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

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

Drug Administration , Priority Review , New Drug Application ,

Tonix Pharmaceuticals Announces Proposed Public Offering

Tonix Pharmaceuticals Announces Proposed Public Offering
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Jessica Morris , Boca Raton , Zembrace Symtouch , Peter Vozzo , Tonix Pharmaceuticals , Exchange Commission , Tonix Pharmaceuticals Holding Corp , Drug Administration , Dawson James Securities Inc , Pharmaceuticals Holding , James Securities , Dawson James Securities , Federal Highway , New Drug Application , Breakthrough Therapy , Private Securities Litigation Reform Act , Annual Report ,

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 Administration , Propharma Group , Appropriate Regulatory , New Chemical Entity , New Drug Application , Abbreviated New Drug Application , Reference Listed Drug , Electronic Common Technical Document ,