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- PMLiVE

Wilson Therapeutics

- PMLiVE

FDA delays decision on Intercept’s NASH drug by three months

Action date pushed back to 26 June

- PMLiVE

FDA committee rejects Intellipharmaceutics’ opioid drug Aximris

Verdict closely follows rejection of Nektar’s opioid analgesic

Bristol Myers Squibb logo

FDA starts priority review of BMS Opdivo/Yervoy in first-line NSCLC

A verdict is expected to be delivered by 15 May

- 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

Solid Bio axes staff by one-third as it clings to troubled DMD programme

Extends company's cash runway up until 2021

- PMLiVE

Apellis jumps as pegcetacoplan tops Alexion’s Soliris in PNH trial

Shares shot up more than 50% in wake of announcement

- 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

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