NICE (UK): Olipudase alfa is not recommended, within its marketing authorisation, for treating acid sphingomyelinase deficiency (ASMD; Niemann–Pick disease) in people with type AB or type B. This… read more.
Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the… read more.
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL)… read more.
Bayer announced that the FDA has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with… read more.
Roche announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for… read more.
UCB announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for at-home self-administration with infusion pump or a new manual push… read more.
Abbott announced new data from its Volt CE Mark Study that show strong safety and efficacy out to 12 months for patients receiving pulsed field ablation (PFA) therapy… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Xofluza. The marketing authorisation… read more.
Merck Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for active immunization… read more.
Astellas Pharma Inc. announced the FDA accepted the revised supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary… read more.
The EMA revealed that Pfizer had withdrawn its application submitted on December 20, 2024, for variation to the marketing authorisation for Ngenla to treat adults with growth hormone… read more.
AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at… read more.
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