US FDA's Arthritis Advisory Committee narrowly votes to expand label for BI's nintedanib for treatment of systemic sclerosis associated interstitial lung disease, with panelists split on whether further data on its risk/benefit profile can be gathered post-approval.
The US Food and Drug Administration's Arthritis Advisory Committee narrowly supported approving Boehringer Ingelheim GmbH's Ofev (nintedanib) for the supplemental indication of systemic sclerosis associated interstitial lung disease (SSc-ILD), leaving the agency to ponder whether it should require more data in the pre- or postapproval phase.
The committee specifically voted 10-7 to recommend backing Ofev at the proposed dose of 150 mg twice daily for the treatment of SSc-ILD
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
