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- PMLiVE

finerenone

- PMLiVE

Roche’s Herceptin/Perjeta fixed-dose combo filed with FDA

Final decision due by 18 October

- PMLiVE

Esperion gets FDA thumbs up for cholesterol drug Nexletol

Big comeback after previous trial fail

Novartis day

Bayer shares dip as Novartis gets EU okay for Beovu in wet AMD

New drug due for launch in Europe in the second quarter

EISAI

Eisai agrees to pull obesity drug Belviq after safety alert

Weight-loss drug linked to increased risk of cancer

- PMLiVE

FDA accepts priority review for Merck’s antibiotic combo Recarbrio

If approved would provide new option for hard-to-treat infections

Blueberry Therapeutics receives clearance from the FDA to proceed with the clinical investigation of BB2603

Blueberry Therapeutics has received an investigational new drug (IND) clearance from the Food and Drug Administration (FDA) to proceed with the clinical development of BB2603

Onyx Health

- PMLiVE

FDA approves Horizon’s thyroid eye disease drug ahead of schedule

First FDA-approved treatment for rare autoimmune condition

- 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

Bayer symbol

Bayer bulks up in women’s health again with non-hormonal contraceptive deal

If approved candidate would become a first-in-category therapy

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