News and Press Releases
Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of...
Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 2025
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Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 18, 2025
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Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD
New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma Itepekimab expanding into chronic rhinosinusitis along with...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025
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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Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia. 3 April...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 3, 2025
TREMFYA (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease
Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 28 March 2025 -- Beerse, Belgium -- Johnson & Johnson today announced that...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 28, 2025
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Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD
Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils Approval marks the first new treatment...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: March 28, 2025
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 25, 2025
Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline
Dren Bio deep B-cell depleter program has the potential to reset the immune system Acquisition underpins path for Sanofi becoming leading immunology company Sanofi to pay $600 million up front....
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 20, 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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Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025
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Opella reaches study milestone for Cialis
21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...
Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025
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
