JD Supra5m
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...
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Non-Opioid Pain Medication Journavx Gets FDA Approval
The Food and Drug Administration has approved a first-of-its-kind non-opioid pain medication, providing a new option for ...
aha.org24m
FDA approves first-in-class non-opioid painkiller
The Food and Drug Administration Jan. 30 announced it approved Journavx (suzetrigine) oral tablets, a first-in-class ...
FDA approved the first new kind of pain medication in 27 years. Here’s how it works
The FDA just approved a new type of pain medication, and it's a non-opioid called suzetrigine that stops body pain at its ...
Healio1h
FDA approves nonopioid Journavx for moderate to severe acute pain
The FDA has approved Journavx 50 mg oral tablets for the treatment of moderate to severe acute pain in adults, according to a ...
The American Journal of Managed Care1h
FDA Approves Celltrion’s Tocilizumab-anoh, Biosimilar to Actemra
Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, potentially expanding treatment access for patients.
Health Affairs1h
We Need More Robust Post-Market Surveillance For Health Care AI
The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.
FDA approves suzetrigine, the first new painkiller since 1998
The Food and Drug Administration announced Thursday its approval of suzetrigine, the first new painkiller greenlit by the agency since 1998.
Vertex Pharma Stock Surges After FDA Approves Non-Opioid Pain Drug
Analyst is bullish on Vertex Pharmaceuticals, citing FDA approval for JOURNAVX and strong earnings growth potential in 2025.
AARP1h
Newly Approved Painkiller Provides Relief Without Addiction
Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental There’s a new way for doctors to treat the ...
FDA Approves New Non-Opioid Painkiller, Journavx: 'No Addiction Potential'
One participant in the drug trial for Journavx said it eliminated her pain without making her feel loopy or nauseous, which ...
Roche Gets FDA Approval for Breast Cancer Test
The Swiss pharmaceutical company said the FDA backed a label expansion for the Pathway HER2 (4B5) test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who could be ...