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.
Pfizer and OPKO Health announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon), a once-weekly injection to treat… read more.
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus… read more.
Moderna, Inc., announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 µg… read more.
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