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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

Curium strikes $8bn deal to buy radiopharma rival Lantheus

Pathos AI signs two cancer deals with Alphamab and AZ

FDA clears Moderna's mRNA-based seasonal flu shot

Sources quash rumours of an AZ/BMS mega-merger

Novo Nordisk wins Netherlands GLP-1 compounding lawsuit

News

Ex-BioNTech execs launch 'AI-native' cancer company

Ex-BioNTech execs launch 'AI-native' cancer company

Two senior executives formerly at BioNTech have launched a new biotech, Bios Life, that they call "an AI-native cancer surveillance company."

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Digital

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