Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
FiercePharma5d
Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...
Managed Healthcare Executive5d
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
JD Supra20h
FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care ...
Managed Healthcare Executive1d
FDA Approves Second Biosimilars for Prolia/Xgeva
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis ...
Medscape3d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...
Hosted on MSN19h
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP)
If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025Priority ...
Finanznachrichten6d
Astellas Pharma Inc.: U.S. FDA Approves Expanded Label for Astellas' IZERVAY (avacincaptad pegol intravitreal solution) for Geographic Atrophy
To date, IZERVAY remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies." The approved label update was based on positive ...
Medscape5d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section ...
FiercePharma5d
Fierce Pharma Asia—Astellas' investment focus; Mitsubishi Tanabe's buyout; Leqembi's 'expansion phase'
4. Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival After an FDA rejection, Astellas’ geographic atrophy med Izervay has secured a much-needed ...