The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are ...
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the ...
GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates. GSK ...
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive ...
The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and ...
Roche’s decision to discontinue the Ionis-partnered trials came soon after the biotech sustained a late-stage failure in ATTR-CM. Roche has discontinued two Huntington’s disease studies for ...
Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, ...
Beautiful, easy data visualization and storytelling The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and ...
The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective. AstraZeneca and Ionis ...
GSK and Alector first partnered in 2021 to advance two antibodies for neurodegenerative diseases. Both assets have since failed to show significant clinical benefit. GSK is officially walking away ...
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