Pharm Exec7d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
GlobalData on MSN13d
Novo Nordisk secures FDA approval for Ozempic in diabetes with CKD
The new indication makes Ozempic the first glucagon-like peptide-1 receptor agonist (GLP-1RA) available for people with T2D ...
Targeted Oncology6d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
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.
Managed Healthcare Executive11d
FDA Approves Journavx, New Nonopioid Med, for Acute Pain
The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid ...
Daily Voice Tolland County CT on MSN11d
FDA Approves First Non-Opioid Painkiller In 20+ Years: 'A Historic Milestone'
The Food and Drug Administration has approved a first-of-its-kind non-opioid pain medication, providing a new option for ...
Medscape13h
Underfunded, Underdiagnosed, and Misunderstood: What’s Next for Bipolar Disorder
BD affects millions but remains misunderstood, underdiagnosed, and underfunded. Researchers are working to change this by ...
Live Science on MSN22h
Hims & Hers Super Bowl controversy: What the ad left out about its 'alternative' weight-loss drugs
The telehealth company Hims & Hers put out a Super Bowl ad that skimped on clarifying that its compounded semaglutide medications aren't FDA-approved.
JD Supra1d
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
JD Supra4d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
The American Journal of Managed Care11d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Today, the FDA granted a label expansion approval for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, a companion diagnostic, to identify patients with HR-positive ...