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Complete Response Letter

News

Red hand for stop at pedestrian light

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

Sushil Patel

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

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 HQ

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.

Editor's Picks

Novo's Wegovy pill cleared for weight loss in EU

Lilly buys into psychedelics with $3.8bn AtaiBeckley deal

Bayer's Kerendia on course for NHS use in heart failure

MSD gets first FDA okay for oral PCSK9 cholesterol drug

GSK abandons cough drug added in $2bn Bellus deal

News

UK biotech venture investment remains buoyant in Q2

UK biotech venture investment remains buoyant in Q2

Venture financing for UK biotechs reached a five-year high in the second quarter of the year, with more than £2 billion raised, says BIA.

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Digital

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The rights of trademark owners are acknowledged. Website and content copyright © 2009-2026, pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company