Topic: marketing approval
Already under shareholder pressure, AMAG faces an uncertain future after an advisory panel recommended the FDA pull Makena from the U.S. market.
AMAG wants to spurn an activist investor’s attempt to take board seats. With a drug prospect’s approval on the line, will the call for change grow?
NICE's backing is a timely win for Novartis' gene therapy ambitions, as it's deeply embroiled in the Zolgensma data manipulation scandal.
Tally another win for Bristol-Myers Squibb’s immunotherapy combination, this time in rare colon cancers.
The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.
It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.
Phase 1 of Bayer’s liver cancer plan is complete: Build a bridge between Stivarga and first-line blockbuster Nexavar.
The new multiple sclerosis med Roche has been anticipating—and the market shake-up other drugmakers have been dreading—is here.
Amgen was aiming to launch its cholesterol-fighter Repatha quickly in India. But a panel of CV and renal specialists blocked the PCSK9 drug instead.
Samsung Bioepis received acceptance of a European Marketing Authorization application for a biosimilar of AbbVie's blockbuster Humira.