FDA has approved the firm's ANDA suitability petitions for floxuridine 500 mg/5 ml injection ready to use solution; cytarabine injection ready to use, 20 mg/ml in 5 ml (non-preserved) single use vials and 25 ml (preserved) multiple dose vials; and dacarbazine 500 mg/vial (lyophilized) for injection.
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Plus deals involving Astellas/Actinium, Sosei/PharmEnable, Aadi/EOC Pharma, BeiGene/Strand, Chi-Med/Inmagene, Alteogen/Intas, Sosei/AbbVie, Y-Biologics/3D Medicines.
If J&J’s gamble on a single dose pays off, it could rapidly advance the fight against SARS-CoV2 – but a second study will provide a safety net.
Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.