Allergan Aesthetics Reports the US FDA’s sBLA Acceptance of Botox Cosmetic for Masseter Muscle Prominence

Shots: The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs…

ByRidhi RastogiAugust 5, 2026

EMA Marketing Authorization of New Drugs in May 2026

Shots: The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen. CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…

ByDipanshu DixitJune 23, 2026

Allergan Aesthetics (AbbVie) Reports CHMP Positive Opinion for Boey to Temporarily Improve Glabellar Lines in Adults

Shots: The CHMP has recommended Boey (trenibotulinumtoxinE) to improve the appearance of mod. to sev. glabellar lines in adults temporarily; decision is expected in the coming mos., & would apply across all 30 EEA states Opinion was supported by data from 2 P-III trials assessing the efficacy & safety of Boey in adults with…

ByRidhi RastogiMay 22, 2026

Allergan Aesthetics Reports the US FDA’s sBLA Acceptance of Botox Cosmetic for Masseter Muscle Prominence

EMA Marketing Authorization of New Drugs in May 2026

Allergan Aesthetics (AbbVie) Reports CHMP Positive Opinion for Boey to Temporarily Improve Glabellar Lines in Adults

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