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NEWS

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…
May 22, 2026

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NEWS

Novartis Receives the CHMP Positive Opinion of Vijoice for PROS Disorders 

Shots:  The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy  EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based…
May 21, 2026

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Boehringer Ingelheim
NEWS

Boehringer Ingelheim Receives the CHMP Positive Opinion of Jascayd for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) 

Shots:  The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF  Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.   Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and…
May 21, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026    

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…
May 19, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Receives Health Canada Approval for  Bevqolva (Biosimilar, Avastin) 

Shots:  Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin  Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations  In 2025, Bevqolva received MHRA approval and was launched in the…
May 1, 2026

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Sanofi
NEWS

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…
April 27, 2026

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Arrowhead Pharmaceuticals
NEWS

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26  Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…
April 24, 2026

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