A supplemental New Drug Application for approval of Zegfrovy (sunvozertinib) in the 1st-line setting has been accepted by the FDA, supported by positive results from the global WU-KONG28… read more.
The National Institute for Health and Care Excellence (NICE) has issued nine Technology Appraisal decisions in August 2026, comprising five positive first recommendations, one updated positive recommendation, and… read more.
Immedica announces that Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D), a… read more.
Egetis Therapeutics AB announced that its partner Fujimoto Pharmaceutical Corporation, which has an exclusive license agreement to develop and commercialize Emcitate (tiratricol) for the treatment of MCT8 deficiency… read more.
NICE (UK) is unable to make a recommendation about the use in the NHS of lisocabtagene maraleucel for treating relapsed or refractory follicular lymphoma in adults after 2… read more.
Knight Therapeutics Inc. announced the launch of Wynzora, a uniform white aqueous cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), in Canada…. read more.
MSD Inc., Tokyo (known as Merck Inc in the USA and Canada) announced that for the Welireg (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor in combination… read more.
Capricor Therapeutics announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, an investigational… read more.
Positive topline results from the DESTINY-Lung04 phase 3 trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard… read more.
Genmab and AbbVie provided clarification on the primary endpoints from the Phase 3 EPCORE DLBCL-1 study evaluating monotherapy epcoritamab (DuoBody-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, compared… read more.
ALK announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the company’s tree pollen tablet (ITULAZAX) and house dust mite tablet (ACARIZAX) for… read more.
Shield Therapeutics announced the publication of the positive efficacy, tolerability and palatability results from the ferric maltol pediatric FORTIS clinical trial, comparing the safety and efficacy of ferric… read more.
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