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- PMLiVE

Orencia

- 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

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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

Bristol Myers Squibb logo

BMS expands collaboration with Nektar, sending shares soaring

Adds research programmes in an additional two cancer types

- 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

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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