Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this year AVT23 was jointly developed by Alvotech & Kashiv BioSciences, with Advanz Pharma obtaining commercial rights to AVT23 in the EEA, UK, Switzerland, Canada, Australia and New Zealand Omalizumab is a humanized mAb that…

ByRidhi Rastogi19 hours ago

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Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

Shots: The UK’s MHRA has approved Oczyesa (octreotide SC depot) for the maintenance treatment in adult with acromegaly who have responded to & tolerated somatostatin analogs, following EC approval on Jun 30, 2025; UK launch expected in Q4’25 Approval was based on extensive data from 7 trials, incl. 4 P-I trials, 1 P-II trials &…

ByRidhi RastogiAugust 29, 2025

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KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The UK’s MHRA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.). Awaits approval in various global markets incl. the EU & Japan Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries, which showed faster symptom relief, reduced attack severity &…

ByRidhi RastogiJuly 16, 2025

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ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Shots: The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA states Approval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some…

ByRidhi RastogiJuly 8, 2025

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Accord Healthcare Reports the MHRA’s Approval of Hetronifly as 1L Treatment of ES-SCLC

Shots: The UK’s MHRA has approved Hetronifly (serplulimab) to treat previously untreated adults in the UK with extensive-stage small cell lung cancer (ES-SCLC) Approval were based on the global P-III (ASTRUM-005) study (n=585) across 128 trial sites, which showed a mFU of 42.4 mos. & 4-year OS rate of 21.9% with serplulimab + CT, confirming its long-term…

ByDipanshu DixitJune 24, 2025

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Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Shots: The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRP Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…

ByRidhi RastogiJune 16, 2025

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UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…

ByRidhi RastogiMay 13, 2025

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Bavarian Nordic Reports the MHRA’s Approval of Vimkunya to Prevent Chikungunya

Shots: The UK’s MHRA has approved Vimkunya for active immunization against CHIKV disease in individuals (≥12yrs.); launch expected in the summer of 2025. Application submitted to Health Canada, with potential approval anticipated in H1’26 Approval was based on 2 P-III trials (n>3,500) that met their 1EP of rapid immune response within 1wk., with 97.8% of…

ByRidhi RastogiMay 2, 2025

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GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…

ByRidhi RastogiApril 21, 2025

NEWS

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

Shots: The CHMP has recommended Xoanacyl (ferric citrate complex) for chronic kidney disease, with an EU decision expected by Jun 2025, while the UK's MAA will be filed via MHRA's IRP, with decision anticipated in the coming mos. MAA was filed via centralized European procedure in Mar 2024 & was supported by 3 pivotal trials…

ByDipanshu DixitApril 2, 2025

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Accord Healthcare Reports the MHRA’s Approval of Hetronifly as 1L Treatment of ES-SCLC

Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Bavarian Nordic Reports the MHRA’s Approval of Vimkunya to Prevent Chikungunya

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Averoa Receives the CHMP’s Positive Opinion for Xoanacyl to Treat Chronic Kidney Disease

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