US FDA Advisory Committee votes to support effectiveness and safety of GSK's respiratory syncytial virus older adult vaccine candidate
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of GSK's respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
Pfizer receives positive FDA Advisory Committee votes supporting potential approval for vaccine candidate to help combat RSV in older adults
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF. The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.
AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate
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- Category: AstraZeneca
AstraZeneca and KYM Biosciences Inc.* have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancer. Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.
Pfizer's elranatamab receives FDA and EMA filing acceptance
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company's Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).
Pfizer announces The Lancet Neurology has published Phase 3 data for zavegepant for the acute treatment of migraine in adults
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced publication of results in The Lancet Neurologyfrom the Phase 3 pivotal clinical trial of zavegepant, an investigational calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. The study met its co-primary endpoints, showing that a single 10 mg dose of zavegepant was more effective than placebo for both pain freedom and freedom from the most bothersome symptom (MBS) at two hours post-dose.
Roche announces donation of essential medicines and diagnostic solutions to the people affected by the devastating earthquake in Türkiye and Syria
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a donation to Türkiye and Syria with a total value of 1.5 million Swiss Francs. This includes medicines, other products and financial support. Among others, we are committed to donating 120,000 packages of Rocephin, a critical antibiotic used to treat the symptoms of many kinds of bacterial infections and listed on the World Health Organization's list of essential medicines.
Kerendia™ (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
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- Category: Bayer
The European Commission granted approval for a label extension for Kerendia™ (finerenone) in the European Union (EU) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D.
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