The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Eliquis… read more.
AbbVie announced positive topline results from the Phase II PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRalpha) positive, platinum-sensitive ovarian… read more.
New recommendations released in Epileptic Disorders by a global expert group comprising epileptologists, neurologists and pharmacologists from Europe and North America address the critical unmet needs associated with… read more.
Vertex Pharmaceuticals Incorporated announced that data on Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor,… read more.
Pfizer Inc. announced longer-term follow-up results from the Phase III CROWN trial evaluating Lorbrena (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name Lorviqua) versus… read more.
The FDA has granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following: i. advanced or… read more.
Positive results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with… read more.
Abbott announced it has received CE Mark in Europe for the AVEIR dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacemaker that treats people… read more.
Moderna, Inc. announced that it has submitted an application to the FDA for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. “For four years, Moderna… read more.
Bristol Myers Squibb announced the first presentation of results from the Phase III CheckMate -9DW trial evaluating the dual immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared… read more.
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization in the EU to Pfizer’s hemophilia B gene therapy Durveqtix (fidanacogene elaparvovec). Durveqtix,… read more.
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Prezcobix (darunavir/cobicistat) to include the treatment… read more.
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