regulatory

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The FDA has started a review of MSD's RSV antibody clesrovimab, a potential rival to Beyfortus, with a verdict due in the middle of next year.

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FDA has sent a complete response letter to J&J, denying approval of its subcutaneous version of lung cancer therapy Rybrevant.

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Readout from NEXUS study sets up mid-2025 refiling for Minoryx and Neuraxpharm's leriglitazone for rare disease cerebral adrenoleukodystrophy (cALD).

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uniQure says it has reached agreement with the FDA on a pathway to accelerated approval for its much-anticipated Huntington's disease gene therapy.

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EU says Novo Holdings’ $16.5 billion takeover of US contract development and manufacturing organisation Catalent does not pose antitrust issues.

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The MHRA isn't sufficiently funded to meet its obligations and that could threaten UK investment in life sciences, according to an ABPI report.