Tag Archives: EU approval

AstraZeneca and Daiichi Sankyo Gain EU Approval for Enhertu as Monotherapy for HER2-Mutant Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo have received European Union (EU) approval for their drug Enhertu as a monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in adult patients with activating HER2 mutations who require systemic therapy … Read the full press release

AstraZeneca’s Tezspire receives EU approval for self-administration in a convenient pre-filled pen for severe asthma patients

(PRESS RELEASE) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced that its drug Tezspire (tezepelumab) has been given the green light for self-administration by the European Medicine Agency’s Committee for Medicinal … Read the full press release

EU Committee for Medicinal Products for Human Use (CHMP) recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma

In the pivotal study, treatment with Gazyvaro plus bendamustine chemotherapy reduced the risk of disease worsening or death by 52 percent compared to bendamustine alone BASEL, 04-May-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU … Read the full press release