The DLL3-targeting bispecific antibody won accelerated approval in extensive-stage small-cell lung cancer among patients treated with platinum chemotherapy.
Amgen, Inc. has an opportunity to take a leading position in a disease area with limited therapy options following accelerated approval of Imdelltra (tarlatamab-dlle) in adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.
The US Food and Drug Administration granted Imdelltra the accelerated approval on 16 May, a month ahead of the 12...
Already approved in two rare obesity conditions, Rhythm’s Imcivree looks on course to gain acquired hypothalamic obesity approval and reach blockbuster status.
Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.
Just days after discontinuing a Phase III trial for a separate MASH compound, Novo Nordisk has secured the US FDA’s accelerated approval for Wegovy to treat the fatty liver disease.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Deal Snapshot: Jazz, which sells Epidiolex for rare seizure disorders, will pay $42.5m up front to take over development of Saniona’s preclinical Kv7.2/Kv7.3 activator SAN2355 for epilepsy.
Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.
All eyes on chronic urticaria after eosinophilic esophagitis disappointment.
