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.
Zealand Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing… read more.
Tris Pharma, Inc., a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced the FDA has approved Onyda XR (clonidine hydrochloride),… read more.
UCB, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorization for… read more.
Valneva SE a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion… read more.
The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are… read more.
PTC Therapeutics, Inc. announced that the European Commission (EC) has decided not to adopt the CHMP’s negative opinion of January 24, 2024 on the annual renewal of the… read more.
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