Managed Healthcare Executive1d
FDA Approves First Generics of Xarelto
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
PharmExec2d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
MyChesCo on MSN4d
FDA Approves Lifesaving Stroke Drug, Xarelto Generics, and Issues Urgent Testosterone Warnings
The U.S. Food and Drug Administration (FDA) has released several important updates addressing new medication approvals and ...
CNET on MSN6d
Natural Medicine vs. FDA Drugs: Which Should You Use for Your Ailment?
FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...
JD Supra10h
FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers
Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties ...
Male enhancement capsules recalled for undeclared ingredients, FDA announces
One Source Nutrition, Inc. is voluntarily recalling all of its Vitality male enhancement capsules nationwide after an FDA ...
Medscape8d
As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?
A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...
Healio2d
FDA accepts new drug application for SYD-101 to treat pediatric myopia progression
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...
Key takeaways from Marty Makary’s FDA confirmation hearing
Marty Makary, a career surgeon and President Trump’s nominee to run the Food and Drug Administration (FDA), faced senators in ...
JD Supra10d
FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Lipocine announces FDA labeling changes for testosterone products
Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...