News FDA dents J&J's blockbuster hopes for Rybrevant FDA has sent a complete response letter to J&J, denying approval of its subcutaneous version of lung cancer therapy Rybrevant.
News Refiling for cALD therapy on the cards after new data Readout from NEXUS study sets up mid-2025 refiling for Minoryx and Neuraxpharm's leriglitazone for rare disease cerebral adrenoleukodystrophy (cALD).
News uniQure rockets on map to market for Huntington's therapy uniQure says it has reached agreement with the FDA on a pathway to accelerated approval for its much-anticipated Huntington's disease gene therapy.
News Novo’s $16.5bn Catalent deal cleared by EU Commission EU says Novo Holdings’ $16.5 billion takeover of US contract development and manufacturing organisation Catalent does not pose antitrust issues.
News MHRA's stature undermined by lack of resources says pharma The MHRA isn't sufficiently funded to meet its obligations and that could threaten UK investment in life sciences, according to an ABPI report.
News Warning letter adds to Applied Tx run of bad news Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.
News Ipsen' Bylvay fluffs its lines in biliary atresia trial Ipsen's IBAT inhibitor Bylvay has failed a trial in biliary atresia, a rare and serious liver disease that affects babies and has limited treatments.
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