approval - International Biopharmaceutical Industry

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How a long shot ALS drug came before the FDA

The drug's beginnings, according to the two former students there to see them, were quite humble. About a decade ago, Justin Klee and Josh Cohen were undergraduates ...

1 April 2022 news ALS | approval

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Spark CEO Marrazzo, who led company to historic gene therapy approval, to step down

Jeffrey Marrazzo, CEO of gene therapy developer Spark Therapeutics, will step down as head of the company he co-founded almost nine years ago, steered to a historic F...

24 February 2022 news approval | CEO

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Bluebird faces longer wait for FDA verdict on experimental gene therapies

Dive Brief: Bluebird bio will need to wait longer for a decision from the Food and Drug Administration on approval of two gene therapies it submitted last year, an...

20 January 2022 news approval | blood

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Merck’s Keytruda gets approval in China for advanced melanoma

Melanoma is one of the fastest growing malignant cancers in China, increasing at an annual rate of 3-5 percent, which makes it one of the deadliest diseases in the co...

31 July 2018 news advanced | approval

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Innovent receives IND approval to initiate Clinical Trials in China

Innovent’s IBI101, is the first OX40-targeted molecule to receive IND approval in China Innovent Biologics, a world-class China-based biopharmaceutical company tha...

27 July 2018 news approval | china

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