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- PMLiVE

Intellipharmaceutics

Biogen Idec building

Biogen and AbbVie bag FDA approval for multiple sclerosis drug

Once-monthly, self-administered Zinbryta ‘significantly’ reduces relapse rate

Teva Pharma logo

FDA turns down Teva’s Huntington’s disease drug

Has requested further analysis on certain metabolites of the chorea candidate

- PMLiVE

FDA gives green light for opioid addiction implant

Titan and Braeburn's Probuphine is first implant of its kind to win US approval

Sanofi reception

FDA panel backs Sanofi’s insulin/GLP-1 agonist combo

iGlarLixi secures endorsement despite concern over its dosing and delivery device

EISAI

Eisai gets green light for Lenvima in kidney cancer

New drug awarded breakthrough and priority review status by FDA in RCC

- PMLiVE

FDA approves expanded indication for Gilotrif

US body gives Boehringer Ingelheim’s oral lung cancer treatment the nod

- PMLiVE

FDA panel says no to quick approval of Clovis’ rociletinib

Recommends waiting for phase III trial results after "serious" safety concerns

- PMLiVE

AbbVie and Roche to launch Venclexta within a week

FDA approves first-in-class BCL-2 inhibitor to treat chronic lymphocytic leukaemia patients

- PMLiVE

FDA panel backs Intercept’s rare liver disease drug

Ocaliva recommended for accelerated approval as a primary biliary cholangitis treatment

- PMLiVE

FDA approves first Remicade biosimilar

Pfizer-Celltrion's Inflectra becomes the second biosimilar to be licensed in the US

- PMLiVE

Gilead boosts liver disease pipeline with $1.2bn acquisition

Also has combination HIV therapy Descovy approved by FDA

- PMLiVE

Jazz Pharma bags FDA approval for rare disease drug

Defitelio given the green light to treat patients who develop severe hepatic VOD

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