Keep track of the latest FDA approvals and regulatory changes impacting the biotech, medtech, and pharmaceutical sectors. Learn how new regulations are influencing healthcare innovation and access to groundbreaking treatments.
The final week of September brought seismic shifts across the pharmaceutical and biotechnology sectors, with an $8 billion oncology acquisition, leadership changes at Big Pharma
The FDA just dropped draft recommendations that could fundamentally change how cell and gene therapies (CGT) get developed and approved. The new guidelines emphasize adaptive
The FDA just delivered hope to families dealing with one of childhood’s most challenging rare diseases. In a groundbreaking decision, the agency has expanded access
In a dramatic reversal that highlights the delicate balance of vaccine development, the FDA has suspended use of the world’s first chikungunya vaccine after recipients
In a landmark decision that could transform treatment for hundreds of thousands of Americans, the FDA has approved Brinsupri (insmedpirdine) as the first-ever medication specifically
Brinsupri becomes groundbreaking DPP1 inhibitor therapy addressing decades of unmet medical need in rare respiratory disease Insmed Corporation achieved a historic regulatory milestone with FDA
Voluntary early-review initiative shifts to preventive manufacturing quality oversight The FDA launched a new “Pre-Check” voluntary program allowing pharmaceutical manufacturers to undergo proactive quality systems
Thermo Fisher’s companion diagnostic enables precision treatment with zongertinib for rare NSCLC subset The FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a
PharmaTher’s KETARx becomes first FDA-approved ketamine formulation for on-label surgical use In a historic regulatory milestone, the FDA approved PharmaTher’s KETARx on August 8, 2025,
Jazz Pharmaceuticals has achieved a groundbreaking milestone in pediatric oncology with the FDA approval of Modeyso (vorasidenib), marking the first systemic treatment specifically approved for
