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- PMLiVE

linaclotide

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Allergan gets FDA nod for first oral CGRP drug for migraine

Extended use into acute treatment of migraine

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FDA clears first generics of Pfizer/BMS’ anticoagulant Eliquis

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

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Intra-Cellular soars on FDA approval of schizophrenia drug

Shares rocketed following the announcement

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FDA rejects ViiV’s long-acting monthly HIV injection

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

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Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

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FDA follows EMA with approval of Merck’s Ebola vaccine

First to be approved in the US

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Trump administration advances drug importation plan

Proposal would allow states to import drugs from Canada

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

Important drug for GSK as it rebuilds R&D pipeline

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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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Horizon looks bright as FDA panel backs eye drug teprotumumab

First alternative to surgery for proptosis

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FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection

Initially had concerns about infection risks and kidney toxicity

- PMLiVE

Biogen defends aducanumab filing plan amid scepticism

A new look at pivotal trial data described as hard-to-interpret

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