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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026    

Shots:  The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.  EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
2 hours ago

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Amgen
NEWS

CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults

Shots: Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factors The recommendation is supported by the P-III (VESALIUS-CV) study involving  ≥12,000 pts., Repatha…
July 31, 2026

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NEWS

Allergan Aesthetics (AbbVie)’s Boey to Temporarily Improve Glabellar Lines in Adults 

Shots:  The EC has approved Boey (trenibotulinumtoxinE) to improve the appearance of mod. to sev. glabellar lines in adults temporarily across all 30 EEA countries  Boey is Europe’s first and only rapid-onset, short-duration botulinum neurotoxin type E, with effects starting in as little as 8 hours and lasting 2–3 weeks.  Boey also received Health Canada approval…
July 16, 2026

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Gedeon Richter
NEWS

Gedeon Richter Receives the EC Approval for Tuyory (Biosimilar, RoActemra) 

Shots:  The EC has approved Tuyory, a biosimilar version of RoActemra (Tocilizumab) across the EEA countries   Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product   Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical …
April 29, 2026

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Merck new
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Merck Report the EC Approval of Enflonsia for RSV Prevention in Infants 

Shots:  The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants  The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…
April 15, 2026

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Gedeon Richter
NEWS

Gedeon Richter Reports the EC Approval of Fylrevy for Hormone Replacement Therapy (HRT) 

Shots:  The EC has approved Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg) across EEA markets  Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women  Preclinical and clinical data show that estetrol (E4) has…
March 27, 2026

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Sanofi
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Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD) 

Shots:  The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg)  Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies  Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…
March 26, 2026

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NEWS

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d) 

Shots:  The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age  Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …
March 26, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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NEWS

Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea) 

Shots:  Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada   The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…
January 29, 2026

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