News and Press Releases
HUTCHMED and Innovent Jointly Announce NMPA Approval for ELUNATE (Fruquintinib) in Combination with TYVYT (Sintilimab Injection) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma
Reduced risk of disease progression or death by 63%, with median PFS of 22.2 months in the FRUSICA-2 registration study 21 May 2026 -- Hong Kong, Shanghai and New Jersey,...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: May 21, 2026
Otsuka Pharmaceuticals UK announces MHRA authorisation of new treatment option for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older
The first ribonucleic acid (RNA)-targeted prophylactic therapy for patients with hereditary angioedema (HAE) to be authorised by the MHRA HAE is a rare and potentially life-threatening genetic condition affecting approximately...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 21, 2026
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Cyclana Bio granted Health Research Authority approval and recruits first patients for clinical observational study in endometriosis
UK NHS grants HRA/REC approval for PEMP study with Peterborough and Cambridge hospitals Clinical observational study investigating underlying biology of endometriosis aims to uncover causal mechanisms and new druggable targets...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 19, 2026
FASENRA approved in US for hypereosinophilic syndrome
14 May 2026 -- Cambridge, UK -- AstraZeneca’s FASENRA (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 14, 2026
CARBOGEN AMCIS Shanghai Site achieves successful outcome in Unannounced NMPA GMP Inspection
China’s NMPA confirms robust GMP compliance at CARBOGEN AMCIS Shanghai, with no observations identified following a comprehensive unannounced inspection 6 May 2026 -- Bubendorf, Switzerland -- CARBOGEN AMCIS, a Switzerland-based...
Category: BioManufacturing, Clinical Trials, Other, Pharmaceutical
Posted: May 6, 2026
Johnson & Johnson’s DARZALEX (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
Landmark decision by CHMP grants approval for self or caregiver administration for patients living with multiple myeloma Milestone is a testament to ten years of daratumumab experience and innovation, continuing...
Category: Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Pharmaceutical
Posted: March 27, 2026
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European Commission approves AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)
Niraparib and abiraterone acetate regimen demonstrates clinically meaningful delay in disease progression, nearly halving the risk of progression or death, with an early trend toward improved overall survival versus standard...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 9, 2026
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Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria
Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies showing Dupixent significantly...
Category: Drug Discovery, Other, Pharmaceutical
Posted: November 25, 2025
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Santhera Announces Approval in Canada for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD...
Category: Other, Pharmaceutical
Posted: October 3, 2025
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argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: June 20, 2025
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European Commission approves subcutaneous RYBREVANT▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation European Commission (EC) approval based on positive...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 7, 2025
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HUTCHMED Announces NMPA Conditional Approval for TAZVERIK (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma
First and only EZH2 inhibitor approved by the NMPA HUTCHMED’s fourth product, and its first approval in hematological malignancies. 21 March 2025 -- Hong Kong, Shanghai & New Jersey, US...
Category:
Posted: March 21, 2025
Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older
Brexpiprazole’s indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older Approval follows a positive Committee for Medicinal Products for Human Use...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 13, 2025
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HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval. 14 January 2025 -- Hong Kong, Shanghai, and New Jersey, US --...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2025
Santhera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS Scotland
AGAMREE® is approved by MHRA for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in UK 14 January 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals...
Category: Other, Pharmaceutical
Posted: January 14, 2025
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
