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Myovant

- PMLiVE

Nektar’s opioid analgesic slammed with FDA panel rejection

Panelists unanimously rejected use of the chronic back pain drug

- PMLiVE

FDA clears Blueprint’s $32k-per-month GI cancer drug

First product approval for rare targeted therapy

- PMLiVE

Allergan gets FDA nod for first oral CGRP drug for migraine

Extended use into acute treatment of migraine

- PMLiVE

FDA clears first generics of Pfizer/BMS’ anticoagulant Eliquis

Sets stage for lower-cost competition to big-selling drug

- PMLiVE

Intra-Cellular soars on FDA approval of schizophrenia drug

Shares rocketed following the announcement

- PMLiVE

FDA rejects ViiV’s long-acting monthly HIV injection

Blow to company as it hopes to capture market share from Gilead

- PMLiVE

Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

- PMLiVE

Trump administration advances drug importation plan

Proposal would allow states to import drugs from Canada

- PMLiVE

GSK files anti-BCMA drug for myeloma after second trial win

Important drug for GSK as it rebuilds R&D pipeline

- PMLiVE

UPDATED: Senate officially confirms Stephen Hahn as FDA commissioner

Final Senate vote was 72 to 18 in favour of the radiation oncology expert

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