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 ...
Managed Healthcare Executive1d
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 ...
Healio11h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Yahoo Finance2d
U.S. FDA Approves Expanded Label for Astellas' IZERVAYâ„¢ (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 ...
Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes
Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® ...
Nasdaq2d
Indivior: FDA Approval Of SUBLOCADE Label Changes Delayed
Meanwhile, on Tuesday, the FDA informed Indivior that ... to provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate. The views and opinions ...
PharmExec2d
FDA Approves SpringWorks Therapeutics’ Gomekli for Neurofibromatosis Type 1, Symptomatic Plexiform Neurofibromas
Approval makes Gomekli the first treatment to be approved for both adults and pediatric patients for neurofibromatosis type 1 ...
Fierce Pharma1d
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 ...
PharmExec3d
FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be ...
Agios Pharmaceuticals: Liver Toxicity Issues May Threaten Thalassemia Approval (Rating Downgrade)
Despite promising Phase 3 results, safety concerns, namely liver injury, have impacted Agios stock and could affect Pyrukund's approval and market adoption. Read the full report here.
Fierce Pharma1d
Pfizer outlines Talzenna's survival benefit in bid for broad prostate cancer approval
Pfizer hopes a unique life-extension benefit for its Talzenna can serve to further expand the drug’s already ...