Skip to content Skip to footer
Subscribe Now
INSIGHTS+

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…
July 21, 2026

Read more

NEWS

Immedica Receives EC Approval for Zepzelca + Tecentriq to Treat 1L ES-SCLC 

Shots:  The EC has approved Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide  Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced the risk of progression or death by 46% & death risk by 27% vs Tecentriq alone. Trial showed mOS of 13.2 vs 10.6mos. & mPFS of 5.4 vs 2.1 mos. for Zepzelca + Tecentriq vs Tecentriq alone,…
June 1, 2026

Read more

INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

Read more

NEWS

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Shots: The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…
October 3, 2025

Read more

Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots
VIEWPOINTS

Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots

Shots:  Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025   Robert Iannone, EVP, Global Head of Research and Development, and Chief Medical Officer at Jazz Pharmaceuticals, in an engaging discussion with PharmaShots, shared insights from the P-III IMforte trial assessing Zepzelca plus atezolizumab in first-line maintenance treatment for Extensive…
August 25, 2025

Read more

Jazz Pharmaceuticals
NEWS

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots: The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025) The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…
June 11, 2025

Read more