News and Press Releases
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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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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European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 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
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 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
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UK’s MHRA grants Promising Innovative Medicine designation to argenx’ investigational therapy, subcutaneous efgartigimod alfa for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)
28 November 2024 -- Gerrards Cross, UK -- argenx, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, confirmed today that its investigational...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: November 28, 2024
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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
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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Merck Receives European Commission Approval for WINREVAIR™ (sotatercept) in Combination With Other Pulmonary Arterial Hypertension (PAH) Therapies, for the Treatment of PAH in Adult Patients With Functional Class II-III
26 August, 2024 – New Jersey, US – Merck, known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in...
Category: Pharmaceutical
Posted: August 28, 2024
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European Commission Approves Astellas’ PADCEVTM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years European Marketing Authorization based on positive overall survival and...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 28, 2024
argenx Announces MHRA Licensing of Subcutaneous VYVGART (efgartigimod alfa) for generalised Myasthenia Gravis
VYVGART is now licensed for both intravenous (IV) and self-administered subcutaneous (SC) use in the UK 7 February 2024 -- Gerrards Cross, UK -- argenx UK, part of argenx, a...
Category: Biotechnology
Posted: February 7, 2024
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European Commission Approves ADCETRIS (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD
· Approval Based on Updated Positive Overall Survival Results from the phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma · First Significant Improvement in Overall Survival in Two Decades...
Category: Pharmaceutical
Posted: October 23, 2023
