Skip to content Skip to footer
Subscribe Now
Moderna
NEWS

Moderna Reports the EC Approval of mCOMBRIAX to Protect Against Influenza and COVID-19    

Shots:  The EC has approved mCOMBRIAX (mRNA-1083), a combination vaccine for the prevention of influenza and COVID-19 in patients ≥50 yrs. across all 30 EEA states    Approval was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone / Efluelda (a high dose influenza vaccine )+ Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability    MRNA-1010, Moderna’s…
April 20, 2026

Read more

Merck new
NEWS

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

Read more

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

Read more

Sanofi
NEWS

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

Read more

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

Read more

NEWS

Formycon Inks Settlement and Licensing Deal with Regeneron & Bayer for Commercialization of FYB203 (Biosimilar, Eylea)  

Shots:  Formycon has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of FYB203, a biosimilar version of Eylea 2 mg (aflibercept 0.05 ml of 40 mg/mL solution), in the EU  Under the agreement, both products may launch in the EU and other regions, including LATAM and Asia-Pacific, from May 2026. Earlier, in October 2025, Formycon secured…
March 19, 2026

Read more

NEWS

Lupin and Sandoz Receive the EC approval for Ranluspec (Biosimilar, Lucentis) 

Shots:  The EC has approved Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)    Ranibizumab is a recombinant humanized IgG1 antibody fragment that inhibits VEGF-A and is used to treat wet AMD, macular edema due to retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization  Sandoz and Lupin Limited partnered in August 2025 to develop and…
February 23, 2026

Read more

Gedeon Richter
NEWS

Gedeon Richter Receives the CHMP Positive Opinion for Fylrevy for Hormone Replacement Therapy (HRT) 

 Shots:  The CHMP has recommended 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); the decision will be anticipated 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…
January 29, 2026

Read more

Sandoz
NEWS

Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)

Shots: The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027 Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy In Dec 2018, Sandoz partnered with…
January 15, 2026

Read more

NEWS

Fondazione Telethon’s Waskyra Receives the EC Approval for Wiskott-Aldrich Syndrome 

Shots:  The EC has approved Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy for Wiskott-Aldrich Syndrome (WAS)    Waskyra is a single-administration therapy that uses a patient’s CD34+ hematopoietic stem and progenitor cells, modified with a lentiviral vector carrying the WAS gene  The EC’s decision follows a CHMP opinion issued in November 2025 recommending marketing authorization, with the same therapy also approved by…
January 9, 2026

Read more

Load more