News and Press Releases
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...
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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
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Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma
Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 13, 2025
Santhera Enters into Supply and Distribution Agreement for AGAMREE (Vamorolone) with Clinigen Group
6 January 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals announces the signing of an exclusive agreement with Clinigen Group to manage the supply and distribution of AGAMREE (vamorolone) in countries...
Category: Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: January 6, 2025
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
China’s National Medical Products Administration (NMPA) approved AGAMREE® for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only...
Category: Other, Pharmaceutical
Posted: December 11, 2024
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
Santhera Receives Positive Recommendation from NICE for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
AGAMREE® has been recommended by NICE for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in England, Wales and Northern Ireland Santhera will be working...
Category: Drug Discovery, Other, Pharmaceutical
Posted: December 10, 2024
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Cancer
First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor 3 December 2024 -- Hong Kong, Shanghai and New Jersey, US — HUTCHMED (China) and Innovent Biologics, Inc...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 3, 2024
Scotland first in the UK to recommend a new treatment option for lung cancer, which could help lower the risk of cancer returning
7 October 2024 -- Scotland, UK -- the Scottish Medicines Consortium has recommended MSD's KEYTRUDA® (pembrolizumab) as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma (NSCLC)...
Category: Other, Pharmaceutical
Posted: October 7, 2024
