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US FDA’s Latest Breakthrough Therapy Awards Include Asthma, Alopecia Areata, And (Of Course) Oncology Therapies

 
• By Bridget Silverman

New BTDs include Loxo’s RET inhibitor for RET fusion-positive lung cancer and RET mutant medullary thyroid cancer, Y-mAbs’ naxitamab for high-risk neuroblastoma, AstraZeneca/Amgen’s tezepelumab for severe asthma, and Pfizer’s JAK3 inhibitor for alopecia areata.

Sunshine

While oncologics remain the mainstay of US FDA’s flagship regulatory incentive program, the breakthrough therapy designation (BTD), recent awards illustrate how the program is encouraging development for unmet needs within big markets like respiratory disease and dermatology.

Respiratory disease, one of AstraZeneca PLC’s primary areas of focus for R&D, has now earned the

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• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

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Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
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