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.
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
In a significant leap forward for medtech innovation, ARS Pharmaceuticals has secured FDA approval for Neffy 1 mg, the first needle-free epinephrine nasal spray designed
Quick Summary •FDA Clearance: LumiThera’s Valeda system becomes the first FDA-approved treatment for dry age-related macular degeneration (AMD). •Technology: Utilizes photobiomodulation (PBM) therapy to stimulate
Pfizer’s Respiratory Syncytial Virus (RSV) vaccine, Abrysvo, recently received FDA approval for use in adults aged 18 to 59 who are at increased risk for
As we move through 2024, the landscape of medical technology and pharmaceutical innovation is being shaped by several high-impact clinical trials. These trials are poised
As we move further into 2024, the medical technology industry continues to innovate at an incredible pace, bringing new devices that improve patient outcomes and
