Shots:
The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma
CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS
The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
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…
Shots:
The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT
Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC
Imdylltra is…
Shots:
The EMA’s CHMP has granted positive opinions and approvals to 5 Biologics and 2 New Chemical Entities in February 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Merck’s Welireg to treat Von Hippel-Lindau & Renal Cell Carcinoma
PharmaShots has compiled a list of 6 drugs…

