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    • Drug Approvals

    An approved drug is a formulation that has been validated for a therapeutic use by a ruling regulatory authority. Here, we cover the latest in big drug approvals and explore how these new therapies could impact the industry. 

    Articles

    FDA hands Biohaven refusal to file letter

    The company plans to request a Type A meeting with the agency to discuss its spinocerebellar ataxia type 3 treatment
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    FDA decisions to watch in 2023

    The agency is facing a busy year, with potential novel drug approvals ranging from gene therapies to RSV jabs

    FDA approves BMS psoriasis TYK2 inhibitor

    The approval hinged on results from BMS’ Phase 3 PSO-1 and POETYK PSO-2 clinical trials, which compared Sotyktu (deucravacitinib), to both a placebo and Amgen’s Otezla

    Fresenius Kabi snags its first biosimilar approval

    Stimufend is now the company’s first approved U.S. biosimilar, but the sixth FDA-approved biosimilar for pegfilgrastim

    FDA approves Imbruvica for kids with chronic graft-versus-host disease

    According to Janssen, 52-65% of children undergoing allogenic transplants develop cGVHD
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    10 tips for improved drug development

    Comprehensive strategies to save time and reduce cost in end-to-end clinical development

    Dermavant snags first novel approval in topical psoriasis treatment in 25 years

    The U.S. regulator has approved Dermavant Sciences' Vtama for the topical treatment of plaque psoriasis — making the cream the first and only FDA-approved steroid-free topical...

    FDA rejects UCB psoriasis blockbuster hopeful

    The FDA delayed its approval decision for UCB’s psoriasis drug bimekizumab Biologics License Application for the second time

    Lilly snags first FDA approval for COVID JAK inhibitor

    After authorizing its emergency use last year, the FDA has approved Eli Lilly’s Olumiant as a treatment for certain patients hospitalized with COVID-19
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    Pulling antibiotics from the fire

    Can policy reform save a market in peril?

    FDA approves BioXcel schizophrenia, bipolar disorder drug

    The drug was developed using the company’s artificial intelligence platform

    Moderna seeks EUA for fourth COVID vax dose

    Moderna has asked the FDA for Emergency Use Authorization of a fourth COVID vax dose for adults 18 and older
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    HIV: An ending in the balance

    Incorporating cures into pharma's HIV epidemic equation

    FDA passes on Gilead HIV drug

    The U.S. FDA said not yet to Gilead Sciences Inc.’s new HIV drug with a complete response letter, after citing quality control issues as the reason for the hold

    FDA says no to Amryt rare skin disease gel

    The FDA has denied approval for Amryt Pharma’s topical gel for a group of rare skin diseases and asked the company to provide additional information