Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. About Piclidenoson ...

Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. Piclidenoson is a novel ...

They consider the FDA compared with the EMA in ... between FDA approval and approval by other regulatory agencies for HIV drugs. Note the significant increase of lag time (dark blue bar) when ...

A new EMA approval has expanded the use of Vertex Pharma’s cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations. The regulator has given a green light ...

Considering Milestone's 2,000 patients worth of drug data across five clinical trials, we believe approval to be imminent for Etripamil and recommend a long position. Editor's note: Seeking Alpha ...

Matt is currently Head of the Coverage Team at The Motley Fool. He has been a full-time Motley Fool employee since 2012 and is a former advisor and analyst for multiple Motley Fool services.

Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. Piclidenoson is a novel, ...

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TORONTO -- John Schneider has been a dozen different dudes since the Blue Jays drafted him 24 years ago. He caught for the Auburn Doubledays, Charleston AlleyCats and Syracuse SkyChiefs, all of them ...

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