Insmed Incorporated announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Brinsupri (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in… read more.
Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with… read more.
Regeneron Pharmaceuticals, Inc. announced the FDA has granted approval for Pasatru (garetosmab-grts) to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans… read more.
NICE(UK): Acalabrutinib plus venetoclax can be used as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. It can only be used: i) without obinutuzumab, and ii)… 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.
NICE(UK): Acalabrutinib plus bendamustine and rituximab can be used, within its marketing authorisation, as an option for untreated mantle cell lymphoma in adults who are not eligible for… 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.
NICE(UK): Donidalorsen can be used as an option to prevent recurrent attacks of hereditary angioedema (HAE) in people 12 years and over, only if: i) they have 2 or more… read more.
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.
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.
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