Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or… read more.
Ultragenyx Pharmaceutical announced that the FDA granted accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), also known as DTX 401, in adult and pediatric patients eight years and older with… read more.
Johnson & Johnson announced U.S. 510(k) regulatory clearance for MONARCH QUEST 3, the latest software update for the MONARCH Platform. The update reflects the company’s continued commitment to… read more.
A new study of sunscreens, baby lotions, shampoos, soaps, and other everyday products found that nearly all contained chemicals not disclosed on their labels. Most contained at least one unlabeled… 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.
Premarket evidence and regulatory characteristics offered little predictive value, researchers report in JAMA Health Forum More than one-third of high-risk therapeutic medical devices authorised for use in the… read more.
The MHRA has approved Romvimza (vimseltinib ) to treat adult patients with tenosynovial giant cell tumour (TGCT) when it impacts movement or where surgery is not an option. TGCT (Giant cell… read more.
Royal Philips announced FDA 510(k) clearance of its next-generation reusable Philips SpO₂ clip sensor, reinforcing the company’s ongoing commitment to providing clinicians with trusted oxygen saturation measurements that… read more.
Emily P. Hyle, MD, and Kenneth A. Freedberg, MD, of the Medical Practice Evaluation Center within the Department of Medicine at Mass General Brigham, are the lead and senior authors of a… read more.
Bristol Myers Squibb announced that the FDA has approved ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple… read more.
Daiichi Sankyo and AstraZeneca announced that Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in China for the first-line treatment of adult patients with unresectable or… read more.
Idorsia Ltd announces that the US Drug Enforcement Administration (DEA) will publish a proposed rule to reclassify dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V… read more.
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