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The EMA is currently reviewing the completeness of the application before initiating the official review process. It is expected that the Committee for Orphan Medicinal Products (COMP) will

Osimertinib is indicated for patients with T790M mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI). Eligibility for treatment with osimertinib will be dependent

The agreement provides ViaCyte with an exclusive license to all BetaLogics intellectual property in the field of metabolic disease, including diabetes, and the transfer of related assets to

The move follows the completion of a phase I study in healthy volunteers. FFP104, which was licensed from PanGenetics, is indicated to treat several autoimmune diseases and inflammatory

Cytori Therapeutics carried out the open-label, single-arm study in Denmark on 17 patients who had undergone radical prostatectomy within 5-18 months before the trial. A single intracavernous injection

The company claims that it is probably the first in the world to file for a global patent for Zika vaccine candidates which it calls Zikavac. The candidates

In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA’s efficacy and safety. The FDA also

In addition, the company announced that it is on track to start Phase II clinical testing in the first half of this year, and that the results of

The completion has resulted in various development programs including those that target AMPK, eiF4E, Metnase, MTH1, PERK, and other indications. The company is working with partners to develop