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Rhythm Pharmaceuticals

Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

Shots: The MHRA has expanded market authorization for Imcivree (setmelanotide) to incl. the treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity due to hypothalamic injury or impairment Approval was backed by the global P-II/III (TRANSCEND) trial assessing Imcivree vs PBO in 120 pts with acquired HO, meeting its 1EP with…

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Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM MHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min Additionally, NICE has recommended aficamten for eligible…

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CuraTeQ

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…

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Hansoh Pharmaceutical Reports the EC Approval of Aumseqa for Non-small Cell Lung Cancer (NSCLC) 

Shots:  The EC has approved Hansoh Pharmaceutical’s Aumseqa (aumolertinib mesylate tablets), marketed as Ameile in China, for use as monotx. in adult pts with advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations in the 1L therapy, and for advanced EGFR T790M mutation-positive NSCLC  Aumseqa is an oral, third-generation EGFR tyrosine kinase inhibitor (TKI) that selectively targets mutated EGFR to inhibit tumor cell growth and reduce the spread of EGFR-mutated lung cancer, while…

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GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

Shots: FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC,…

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Klinge Pharma Partners with NTC to Commercialize FYB203 (Biosimilar, Eylea) in Italy

Shots: Klinge Pharma, holder of global commercialization rights for Formycon’s FYB203, has entered into an exclusive agreement with NTC to commercialize FYB203, a biosimilar version of Eylea (aflibercept), in Italy As per the deal, Klinge will receive royalties on net sales, with Formycon participating in these payments in the mid-single to low-double-digit % range, while…

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Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026 Approval was based on extensive clinical data, incl. P-III (ASPEN)…

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Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Shots: The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…

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Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases

Shots: The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…

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