News Manufacturing issues mar ITM's radiopharma filing, says FDA ITM's first attempt to score FDA approval for one of its radiopharma therapies has been knocked back by the agency.
News Unicycive hits another hurdle with hyperphosphataemia drug Unicycive Therapeutics' hopes of getting FDA approval of its drug for hyperphosphataemia in dialysis patients have been knocked back again.
News FDA hands another rejection to Replimune's melanoma therapy Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.
News FDA knocks back Biogen's high-dose Spinraza Biogen's efforts to defend its SMA business have been dealt a setback after the FDA declined to approve a high-dose version of Spinraza.
News Replimune receives CRL on BLA for RP1 for advanced melanoma Replimune has announced the FDA has issued a Complete Response Letter regarding the Biologics License Application for RP1 combined with nivolumab.
News ESC26: Isomab safety evidence on blood vessel growth for CAD Isomab has presented landmark safety data at ESC, clearing the path for next-generation therapies to promote blood vessel growth in CAD.
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