Global Blood Therapeutics announced the European Commission (EC) has granted Marketing Authorization for Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in… read more.
Heron Therapeutics, Inc., announced that Health Canada has issued a Notice of Compliance (NOC) to commercialize Zynrelef (bupivacaine and meloxicam extended-release solution) for instillation into the surgical wound… read more.
Pfizer Inc. announced that the FDA has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar… read more.
GlaxoSmithKline plc announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the… read more.
Amgen announced results from a pooled post-hoc analysis of the pivotal NAVIGATOR Phase III and PATHWAY Phase IIb trials showed Tezspire (tezepelumab-ekko) demonstrated reductions in the annualized asthma… read more.
LEO Pharma announced up to 3.5-year data that further support the long-term safety and efficacy profile of Adbry (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD). The… read more.
AbbVie announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar) to the FDA for the adjunctive treatment of major depressive disorder (MDD) in… read more.
Genentech, announced that new two-year data from its Phase III studies of Vabysmo (faricimab-svoa) and Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant will be… read more.
Takeda announced the first six-month interim analysis results from INSPIRE, in which clinical remission was observed in 65% of patients in both cohorts who were evaluated at 6… read more.
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy… read more.
The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia from Bayer HealthCare. Kerendia (10 mg or 20 mg),… read more.
Hansa Biopharma AB, the pioneer in enzyme technology for rare immunological conditions, announced that its first-in-class treatment Idefirix (imlifidase) has been granted early access post marketing authorization (Autorisation… read more.
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