Moderna’s Scores FDA Approval For Its Second Product – Respiratory Syncytial Virus Vaccine
FDA approves Moderna's mRESVIA (mRNA-1345), an mRNA vaccine for RSV, for adults 60+. The second approved mRNA product from Moderna.
Novartis’ Oral Drug For Chronic Skin Disease Candidate Shows Efficacy, Long-term Safety
Novartis reveals Phase 3 data confirming remibrutinib's long-term efficacy and safety for chronic spontaneous urticaria, showing significant symptom improvement and a favorable safety profile up to Week 52.
Europe Approves Biogen’s Tofersen For Adult Patients With Rare Type Of Neurodegenerative Disorder
The European Commission has granted exceptional marketing authorization for Biogen's Qalsody (tofersen), the first EU-approved treatment targeting the genetic cause of ALS.
Summit Therapeutics’ Lung Cancer Therapy Ivonescimab Shows Improved Progression-Free Survival Versus Merck’s Multi-Billion Keytruda In China Study
Summit Therapeutics shares dropped 27.3% to $7.94 in premarket trading Friday after a 272.1% surge on Thursday. The company announced Phase 3 HARMONi-2 trial results, where ivonescimab significantly improved progression-free survival in NSCLC patients compared to Keytruda.
Takeda Gets Positive CHMP Opinion For Recombinant ADAMTS13 In Congenital Thrombotic Thrombocytopenic Purpura
cTTP Is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90%1,2If Approved in the European Union, rADAMTS13 Will Be the
Gilead’s Trodelvy Fails To Hit Primary Goal In Late-Stage Study With Most Common Type Of Bladder Cancer
Gilead Sciences' announced topline results from the Phase 3 TROPiCS-04 study on Trodelvy for metastatic urothelial cancer. The study did not meet the primary endpoint of overall survival but showed numerical improvements favoring Trodelvy.
FDA Extends Review Deadline For Regeneron/Sanofi’s Dupixent For ‘Smoker’s Lungs’ Disease
The FDA extends the target action date for reviewing Dupixent as an add-on treatment for uncontrolled COPD to September 27, 2024. This follows the submission of additional efficacy analyses from pivotal trials. European Medicines Agency also supports Dupixent for COPD.
Mirum Pharmaceuticals Gets Positive CHMP Opinion For LIVMARLI Oral Solution For The Treatment Of PFIC In Patients 3-Months Or Older
Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in pruritus severity between LIVMARLI vs. placebo across all PFIC types studied.CHMP assessment
Novartis Scemblix Phase III Data Shows Superior Efficacy With A Favorable Safety And Tolerability Profile Vs. Standard-Of-Care TKIs In Adults With Newly Diagnosed CML
https://www.novartis.com/news/media-releases/novartis-scemblix-phase-iii-data-first-show-superior-efficacy-favorable-safety-and-tolerability-profile-vs-standard-care-tkis-adults-newly-diagnosed-cml Phase
Gilead Sciences To Present EVOKE-01 Study Results In Metastatic NSCLC At An Oral Session At ASCO 2024
– Simultaneously Published by the Journal of Clinical Oncology –Gilead Sciences, Inc. (NASDAQ:GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract