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.
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 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.
Pfizer Inc. announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase III clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of… read more.
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… 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 the medicinal product Talzenna…. read more.
The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome (Ph)–positive, chronic-phase chronic myelogenous leukemia (CP-CML) that… read more.
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe… read more.
Pfizer announced that the European Commission (EC) has granted marketing authorization for Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both… read more.
Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for… read more.
Pfizer Inc. announced the FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received… read more.
The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is… read more.
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