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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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INSIGHTS+

The US FDA New Drug Approvals in February 2026 

Shots:  Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.  Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia  Overall, February 2026 reflected…
March 10, 2026

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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
March 3, 2026

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NEWS

Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid) 

Shots:  The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and  NovoRapid, respectively, across all 30 EEA states  Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.  Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz…
February 27, 2026

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Gedeon Richter
NEWS

Gedeon Richter Receives the CHMP Positive Opinion for Tuyory (Biosimilar, RoActemra) 

Shots:  The CHMP has recommended marketing authorization for Gedeon Richter’s Tuyory, a biosimilar version of RoActemra (Tocilizumab)  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 …
February 27, 2026

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Novartis
NEWS

Novartis Reports the CHMP Positive Opinion for Remibrutinib for Chronic Spontaneous Urticaria (CSU) 

Shots: The CHMP has recommended approval of remibrutinib for CSU in adults with inadequate response to H1-antihistamines, with a final decision from the EC expected within ~2 mos.  Opinion was supported by the global P-III REMIX-1 & 2 trials in 925 pts uncontrolled on second-generation H1-antihistamines, where remibrutinib showed superiority vs PBO in ISS7, HSS7 & UAS7 at Wk 12, with itch and hive improvement from Wk 1 sustained to Wk 52, along with…
February 26, 2026

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Moderna
NEWS

Moderna’s mCOMBRIAX Receives the CHMP Positive Opinion to Protect Against Influenza and COVID-19   

Shots:  The CHMP has recommended approval of mCOMBRIAX (mRNA-1083), a combination vaccine for prevention of influenza and COVID-19 in patients ≥50 yrs. If granted, the approval would be valid in all 30 EEA states  Opinion 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 High‑Dose / Efluelda + Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where…
February 26, 2026

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NEWS

Formycon and Zydus Lifescience Report Successful Clinical Development of FYB206 (Biosimilar, Keytruda) 

Shots:  Formycon & Zydus Lifescience has reported that the pivotal Dahlia PK study of FYB206, a biosimilar version of Keytruda (pembrolizumab), has met its 1EP   The multicenter PK study showed bioequivalence of FYB206 (pembrolizumab) to Keytruda   Zydus Lifesciences has exclusively in-licensed FYB206, a proposed biosimilar to Keytruda (pembrolizumab), from Formycon for the US and Canada   Ref: Zydus Lifesciences | Image: Zydus Lifesciences and Formycon | Press Release  Related…
February 25, 2026

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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

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Roche
NEWS

The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer

Shots: The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
February 20, 2026

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