The expanded approval covers children and teens with chronic conditions that increase vulnerability to pneumococcal infections
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)
The newly approved treatment, SKINVIVE by JUVÉDERM, is now the first and only hyaluronic acid injectable cleared specifically for improving neck appearance
Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes
The FDA nod marks a step forward in precision oncology, linking molecular diagnostics more tightly to therapy selection for advanced prostate cancer
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
MeRT becomes one of the few FDA-cleared neuromodulation therapies for PTSD, using EEG biomarkers and AI to personalize treatment for patients with treatment-resistant symptoms
The regulatory decision follows promising results from RIVER-81
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
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