Category: emd serono

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

(pirfenidone), (RC48), (TAK-788), 2020, 89Zr-girentuximab, Amgen, APR-246, Aprea, Astellas. Seattle Genetics, AstraZeneca, Avelas, AXS-05, Axsome, baricitinib, Bavencio (avelumab), BeyondSpring, Breakthrough Therapy Designation, Brensocatib, Concert, ContraFect, CTP-543, Cyprium, D-PLEX₁₀₀, Daiichi Sankyo, Debio 1143, Debiopharm, Disitamab Vedotin, Eli Lilly, emd serono, ER-004, Esbriet, Exebacase, F2G, FDA, Genentech, Gilead, IMGN632, ImmunoGen, Insights, Insmed, Inventiva, IO Biotech, Janssen, JNJ-6372, Junshi, KEYTRUDA, Kiniksa, Lanifibranor, Magrolimab, mavacamten, Merck, Mobocertinib, Mosunetuzumab, MyoKardia, Novartis, Olumiant, osimertinib, Padcev, Pfizer, PolyPid, RemeGen, Repotrectinib, Resverlogix, Roche, Tagrisso, Takeda, TLX250-CDx, Toripalimab, Turning Point, US, ViiV Healthcare, Vixarelimab, Zanidatamab, Zymeworks / March 11, 2021 March 11, 2021

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

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