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European Commission Approves Pfizer's PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease -March 13, 2024 at 04:03 am EDT

PREVENAR 20® offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of...
United States European Commission Decision Pfizer Inc Drug Administration Exchange Commission European Union

European Commission Approves Pfizer's PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease

NEW YORK, March 13, 2024--Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for the company’s 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
United States European Union European Commission Exchange Commission National Center Drug Administration
Source: yahoo.com

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Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Submission is based on 2-year confirmatory results from the Phase 3 PROTECT Study in which FILSPARI demonstrated a significant reduction in proteinuria, preservation of kidney function and a generally...
Deric Dube Travere Therapeutics Inc Drug Administration European Commission European Union European Medicines Agency

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and immunogenicity profiles were comparable between switching group and continuous reference product Humira group 52-week results from SB17 Phase 3 study demonstrated long-term efficacy, safety, and immunogenicity of SB17 compared to reference ustekinumab, including switching from ustekinumab to SB17 IN...
United States San Diego Skaidra Valiukevi Maria Agnieszka Zegadlo Mylik Lidia Rajzer Ilsun Hong
Source: yahoo.com

Primodos: MPs say 'covered-up' evidence could reveal 'one of the biggest medical frauds of 20th century'

An expert working group in 2017 found there was insufficient evidence of a causal association between the Primodos hormone pregnancy test and birth defects - but a team of Oxford academics used the same raw data and got opposite results.
United Kingdom Marie Lyon Carl Heneghan Yasmin Qureshi Party Parliamentary Group Commission On Human Medicines
Source: sky.com

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