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Bristol's Opdivo Diversifies Options In Liver Cancer

 
• By Emily Hayes

Response rate data supports yet another supplemental approval for Opdivo in an underserved tumor type that is becoming more competitive.

FDA approved background, 3D rendering, blue street sign

The US FDA's accelerated approval of Bristol-Myers Squibb Co.'s PD-1 inhibitor Opdivo for second-line hepatocellular carcinoma paves a path for checkpoint immunotherapies in yet another traditionally underserved tumor type.

FDA announced the new approval of Opdivo Sept

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Verastem Wins Approval For Novel Drug Combo In Rare Ovarian Cancer

 
• By Jessica Merrill

The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

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Q1 S&E In Brief: Tracking New Launches And Catalysts In Biopharma

 
• By Jessica Merrill and Joseph Haas

Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Building Up US Biopharma Manufacturing Will Require Investments In Talent

 
• By Jessica Merrill

Workforce development will be essential to meeting president Trump’s goal to return biopharma manufacturing to the US.