JUVÉDERM® VOLUMA® XC Now Nationwide for Treating Moderate to Severe Temple Hollowing
Key TakeawaysJUVÉDERM® VOLUMA® XC, the first and only FDA-approved hyaluronic acid filler for temple hollowing, is now available across the U.S.
Over 85%...
Dry Eye Disease Treatment Advances with Reproxalap’s Resubmitted FDA Application
Key TakeawaysAldeyra Therapeutics has resubmitted its New Drug Application for reproxalap to the FDA, seeking approval for its use in treating the signs...
Key TakeawaysThe FDA has granted Priority Review to Enhertu for the treatment of HER2-low and HER2-ultralow metastatic breast cancer, based on positive results...
Key TakeawaysThe FDA has officially declared the end of the shortage for Eli Lilly’s Mounjaro and Zepbound, signaling improved availability of these popular...
Mantle Cell Lymphoma Treatment Advances with FDA Priority Review for Calquence
Key TakeawaysThe FDA has granted Priority Review for AstraZeneca's Calquence, a promising new treatment for untreated mantle cell lymphoma, based on data showing...
Non-Small Cell Lung Cancer Treatment Advances with FDA Approval of Perioperative Opdivo Regimen
Key TakeawaysThe U.S. FDA has approved Opdivo in combination with chemotherapy for the perioperative treatment of resectable non-small cell lung cancer, marking a...
FDA Clarifies Compounding Rules as National GLP-1 Drug Supply Stabilizes
Key TakeawaysThe FDA announces that the national shortage of tirzepatide injection, a GLP-1 medication, has been resolved.
The agency reminds compounders of legal...
Thrombectomy System Receives FDA Clearance for Pounce™ XL, Expanding Treatment Range
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Key TakeawaysSurmodics has received FDA 510(k) clearance for its Pounce™ XL Thrombectomy System, expanding its thrombectomy platform to treat larger peripheral arteries up...
A New Hope for Schizophrenia Treatment with Cholinergic Receptor Targeting: FDA Approves Cobenfy
Key TakeawaysClinical trials indicate significant symptom reduction in schizophrenia patients.
Cobenfy offers an innovative treatment option by targeting cholinergic receptors.
Patients must be...
Biosimilar Otulfi™ Receives FDA Approval, Offering New Treatment Options for Inflammatory Diseases
Key TakeawaysBiosimilar Otulfi™ (ustekinumab-aauz) has received FDA approval for both subcutaneous and intravenous formulations, providing a cost-effective alternative to Stelara® for treating Crohn’s...
