EMA Marketing Authorization of New Drugs in June 2026

Shots: The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon. European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…

ByDipanshu DixitJuly 21, 2026

Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao

Shots: Merz has granted Kvvit exclusive license to Inbrija (levodopa inhalation powder) in mainland China, Hong Kong, & Macao for intermittent treatment of OFF episodes in adults with Parkinson’s disease receiving levodopa/dopa-decarboxylase inhibitor Merz will supply Inbrija, oversee global quality & key regulatory activities, & act as Overseas Holder of the Drug Registration Certificate, while…

ByRidhi RastogiMay 26, 2026

AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease

Shots: The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed…

ByRidhi RastogiSeptember 29, 2025

EMA Marketing Authorization of New Drugs in June 2026

Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao

AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease

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