PipelineReview.com. Biopharmaceutical News & Clinical Trials
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网页5 天之前 · PipelineReview.com is powered by La Merie Business Intelligence For immediate assistance, please call us during business hours: Mon-Fri 10:00am - 05:00pm; GMT+01 La Merie Publishing - Ulrich Martin Veinat Puigsec - Can Magí s/n | 17862 Vallfogona de Ripollès | Spain | T +34-87-200 1365 | Email [email protected]
RYBREVANT® (amivantamab-vmjw) plus standard of care …
网页1 天前 · Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT ® this year, with four indications overall. RARITAN, NJ, USA I September 19, 2024 I Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT ® (amivantamab-vmjw) in combination with standard of care ...
FDA Approves First Treatment for Niemann-Pick Disease, Type C
网页16 小时之前 · SILVER SPRING, MD, USA I September 20, 2024 I Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and ...
Ipsen’s Iqirvo® (elafibranor) approved in the European Union as …
网页16 小时之前 · European Commission grants conditional marketing authorization for Iqirvo ® (elafibranor), first-in-class new treatment for primary biliary cholangitis (PBC), a rare liver disease; Approval follows positive CHMP opinion based on ELATIVE phase III trial data, which demonstrated significant efficacy over placebo and was well-tolerated with an acceptable safety profile
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron …
网页16 小时之前 · Custom Report. La Merie Publishing offers the service of preparing customized reports tailored to the needs and specifications of the customer. We conduct scientific & medical literature evaluations for clients of the biopharmaceutical industry within the scope of our expertise.
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for ...
网页16 小时之前 · OPUVIZ™, a biosimilar referencing Eylea 1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency; INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA ...
Boehringer’s nerandomilast meets primary endpoint in pivotal …
网页4 天之前 · INGELHEIM, Germany I September 16, 2024 I Boehringer Ingelheim announced today that the FIBRONEER™-IPF trial met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] (FVC) at week 52 versus placebo. FVC is a measure of lung function. 1 Based on these ...
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus …
网页2021年10月14日 · This Is the First Anti-PD-1 Combination Approved as First-Line Treatment for These Patients. KENILWORTH, NJ, USA I October 13, 2021 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the ...
Kynos Therapeutics announces positive top-line results from the …
网页EDINBURGH, UK I April 22, 2024 I Kynos Therapeutics Ltd, a clinical-stage biotechnology company developing first-in-class small molecule kynurenine 3-monooxygenase (KMO) inhibitors for acute and chronic inflammatory disorders, today announces the key findings from the first-in-human Phase I trial of its lead drug candidate, KNS366.. KMO is an enzyme that acts at a key point in the kynurenine ...
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