Pharm Exec4 天
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
pharmaphorum3 天
FDA expands label for Roche's eye disease implant Susvimo
The new indication adds to the 2021 approval of Susvimo (ranibizumab) for 'wet' or neovascular age-related macular ...
Targeted Oncology3 天
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 ...
Senators warn FDA about Super Bowl commercial believed to mislead patients
A group of Senators has warned the FDA about an ad expected to air during Sunday’s big game that they believe misleads ...
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 ...
oncnursingnews3 天
T-DXd Companion Diagnostic in HER2-Ultralow Metastatic Breast Cancer Gains FDA Approval
The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.
dvm3604 天
Drug label is updated for pain management therapy
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
JD Supra1 天
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 ...
Medscape23 小时
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
The labeling, or prescribing information, is thus subject to FDA regulations and is a requirement for all approved drug and biological drug products. A label contains information necessary for ...
MyChesCo on MSN5 天
FDA Approves First-in-Class Non-Opioid Pain Drug Journavx
The U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine) 50 milligram oral tablets, a groundbreaking ...
PharmiWeb3 天
FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the ...
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema ...