Pneumococcal Pneumonia Vaccination for High-Risk Adults
A campaign from the American Lung Association urges vaccination for pneumococcal pneumonia, which hospitalizes 225,000 Americans each year.
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Pneumococcal Pneumonia Vaccination for High-Risk Adults
A campaign from the American Lung Association urges vaccination for pneumococcal pneumonia, which hospitalizes 225,000 Americans each year.
Read MorePositive Topline Data for Comirmaty LP.8.1 COVID-19 Vaccine
Preliminary data show the Comirnaty COVID-19 vaccine increases neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2.
Read MoreFDA Approves Comirnaty COVID-19 Vaccine
The FDA approved Pfizer/BioNTech’s Comirnaty LP.8.1 COVID-19 vaccine for adults age 65+ and those age 5-64 years old with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
Read MorePositive CHMP Opinion for Comirnaty LP.8.1-adapted COVID-19 Vaccine
The European Medicines Agency’s CHMP recommended marketing authorization for the Pfizer/BioNTech’s LP.8.1-adapted monovalent COVID-19 vaccine (Comirnaty LP.8.1).
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FDA Mandates Updated Warning Labels for mRNA COVID-19 Vaccines
The FDA now requires certain COVID-19 vaccines to include safety information about the risks of myocarditis and pericarditis following administration.
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Researchers Question Paxlovid’s Impact on COVID-19 Outcomes
Paxlovid does not significantly reduce COVID-19 hospitalization and mortality among vaccinated older adults, according to UCLA-led research.
Read MorePfizer’s RSV Vaccine Approved for Adults Down to Age 18
The FDA has approved Pfizer’s RSV vaccine, Abrysvo, for adults aged 18 to 59 who are at increased risk of lower respiratory tract disease caused by RSV, expanding its previous indication for adults aged 60 and older.
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FDA OKs Updated Moderna and Pfizer-BioNTech COVID-19 Vaccines
The FDA has approved and authorized updated Moderna and Pfizer-BioNTech COVID-19 vaccines for the 2024-2025 season, designed to target current variants.
Read MorePfizer and BioNTech Report Mixed Results in Phase 3 Flu-COVID Vaccine Trial
The vaccine candidate showed strong responses against influenza A and COVID-19 but did not meet its goal for influenza B.
Read MorePfizer’s RSV Vaccine Shows Promise in Immunocompromised Adults
Pfizer’s Abrysvo demonstrated a strong immune response and favorable safety profile in immunocompromised adults at high risk of severe RSV.
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Lorlatinib Improves Progression-Free Survival in ALK-Positive NSCLC Trial
After five years, 60% of patients remain alive without disease progression, compared to 8% on the crizotinib treatment arm.
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Cleveland Clinic Enrolling Long COVID patients in Clinical Trial
The Cleveland Clinic ReCOVer Clinic is enrolling Long COVID patients in the NIH RECOVER-VITAL clinical study.
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Canada Approves Pfizer’s RSV Vaccine
The vaccine was approved for older adults and infants through maternal immunization.
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FDA Approves Pfizer’s Drug Combo for Specific Lung Cancer Mutation
The FDA approved the combination therapy—previously approved for certain metastatic melanoma patients—for the treatment of metastatic non-small cell lung cancer with a BRAF V600E mutation.
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CDC Endorses Pfizer’s Maternal RSV Vaccine to Shield Newborns
Members of the Advisory Committee on Immunization Practices voted 11-1 to recommend the maternal RSV vaccine for pregnant people to prevent RSV lower respiratory tract infection in infants.
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FDA Approves Updated COVID Vaccines from Pfizer and Moderna
The mRNA vaccines are formulated to more closely target currently circulating variants by including a monovalent component that corresponds to the Omicron variant XBB.1.5.
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Pfizer and BioNTech Get Positive EU Opinion for Updated COVID-19 Vaccine
The companies also filed an application with the FDA requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older.
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FDA Approves First RSV Vaccine for Use During Pregnancy
The US FDA expanded Pfizer’s Abrysvo (RSV vaccine) for use during pregnancy to prevent LRTD caused by RSV in infants from birth through 6 months of age.
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FDA Approves Pfizer’s RSV Vaccine
The FDA approved Abrysvo for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years and older.
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FDA Approves Paxlovid for High-Risk COVID-19 Patients
Pfizer’s Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
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FDA Approves 20-valent Pneumococcal Vaccine for Infants and Children
The vaccine builds on the company’s previously approved vaccine by including seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases.
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Bivalent Pfizer Booster Authorized for Infants and Young Children
The FDA expanded emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as a single booster dose for children 6 months through 4 years of age.
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Five RSV Articles for the Week
FDA panel favors approval for two RSV vaccines, ‘Tripledemic’ hits US households, and a monoclonal antibody may be ready for next season—here are five RSV stories you should check out this week.
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FDA Panel to Convene to Review Promising RSV Vaccine Candidates
The FDA accepted Biologics License Applications and granted priority review for both Pfizer and GSK’s RSV older adult vaccine candidates last year following positive data from phase 3 trials.
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