Jazz described the readout as boosting its confidence that it has a HER2-targeted “agent-of-choice” for first-line patients with HER2-positive gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus. More: Jazz's HER2 drug Ziihera chalks up another win
read moreThanks to a new accord with the United States, import tariffs on many key goods from Liechtenstein and Switzerland—including pharmaceuticals—will be capped at 15%, falling in line with the terms in an EU agreement the U.S. signed in August. More:
read moreThe updated label now includes a boxed warning and a new “limitation of use” in addition to the removal of the prior indication for non-ambulatory patients with Duchenne muscular dystrophy. More: FDA restricts Sarepta's gene therapy Elevidys after Duchenne patient
read moreThe European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) cleared 10 products in total, including two biosimilars and two generics. More: Otsuka's HAE med Dawnzera, Lilly's oral SERD Inluriyo among drugs scoring EU endorsements Source: fierce
read moreLB Pharmaceuticals and Celldex have separately stepped up their respective launch preparations by appointing new chief commercial officers. More: LB Pharmaceuticals, Celldex hire commercial chiefs as launch plans ramp up Source: fierce
read moreThe FDA said Thursday that it has approved Organon and Henlius Biotech’s Poherdy as an interchangeable biosimilar to Perjeta. The approval covers the Roche drug’s existing HER2-positive breast cancer indications. More: Organon and Henlius' Poherdy, first biosimilar to Roche's Perjeta,
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