FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17
The USFDA approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years, according to Merck.
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FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17
The USFDA approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years, according to Merck.
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FDA Expands Winrevair Approval for Pulmonary Arterial Hypertension
Winrevair is now FDA-approved to treat pulmonary arterial hypertension to improve exercise capacity and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.
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Winrevair Reduced Risks of PAH Worsening Events
Results from a Phase 3 clinical study of adults with pulmonary arterial hypertension found Winrevair reduced the risk of clinical worsening events by 76%.
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FDA Approves Keytruda Qlex for Subcutaneous Injection
As a subcutaneous injection, Keytruda Qlex may provide added convenience compared to IV Keytruda because it can be administered by HCPs in multiple settings.
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Merck to Acquire Verona Pharma and Its Ohtuvayre COPD Drug
Merck will acquire Verona Pharma’s FDA-approved ensifentrine/Ohtuvayre for the maintenance treatment of COPD in adult patients.
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ACIP Recommends Enflonsia to Prevent RSV-related LRTIs for Infants Under 8 Months
After receiving FDA approval earlier this month, Merck’s Enflonsia was recommended by the CDC’s ACIP for the prevention of RSV lower respiratory tract disease in infants under 8 months entering their first RSV season.
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FDA Approves Enflonsia to Prevent RSV-related LRTIs in Neonates
The FDA approved Enflonsia, a long-acting monoclonal antibody designed to protect neonates and infants from RSV-related lower respiratory tract disease.
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CDC Lowers Age for Pneumococcal Vaccination from 65 to 50
Lowering the age gives more adults the opportunity to protect themselves from pneumococcal disease at an age when the risk of infection increases, according to the CDC.
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Merck Stops Late-Stage Trial of Vibostolimab-Pembrolizumab Combo in Small Cell Lung Cancer
The phase 3 trial was investigating the vibostolimab and pembrolizumab combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer.
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Merck’s Investigational RSV Shot Protects Infants in Phase 2b/3 Trial
The trial showed that clesrovimab reduced RSV-related respiratory infections in infants through day 150.
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FDA Greenlights Ensifentrine/Ohtuvayre for COPD
The inhaled therapy for the maintenance treatment of COPD combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule.
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USDA Approves First RNA-Based Dog Flu Vaccine
A new RNA-based vaccine approved by the USDA offers protection against the year-round threat of canine influenza.
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FDA Approves Merck’s Pneumococcal Vaccine for Adults
The vaccine covers serotypes responsible for approximately 84% of invasive pneumococcal disease in adults 50 years of age and older.
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FDA Approves Merck’s Injection for Pulmonary Arterial Hypertension
The injection on top of background therapy significantly improved exercise capacity and multiple secondary outcome measures compared to background therapy alone.
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FDA Grants Priority Review to Merck’s Pneumococcal Conjugate Vaccine for Adults
The FDA accepted for priority review a new Biologics License Application for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
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Merck’s COVID Drug May be Causing the Virus to Mutate
Researchers identified unusual COVID-19 mutation patterns that were strongly associated with molnupiravir use and coincided with the drug’s introduction.
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Ebola Vaccine Approved in Children Age 1 and Older
The FDA approved an expanded indication for Merck’s Ervebo vaccine, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.
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Gefapixant Gets European Medicines Agency’s Backing for Chronic Cough
Merck’s investigational drug for chronic cough is one step closer to coming to market after receiving a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Read MoreFDA Green-lights Merck’s MMRV Vaccines for Intramuscular Injection
With these approvals, healthcare professionals now have the option to administer Merck’s measles, mumps, rubella, and varicella vaccines intramuscularly.
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Merck’s Keytruda Meets Primary Endpoint in Phase 3 Trial for Lung Cancer
The US Food and Drug Administration has accepted Merck’s new supplemental Biologics License Application based on data from the trial.
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FDA Approves Vaxneuvance Pneumococcal Vaccine for Infants, Children
The FDA has expanded the approval for Merck’s Vaxneuvance for prevention of invasive disease caused by Streptococcus pneumoniae to include children 6 weeks through 17 years of age.
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FDA Authorizes Merck Molnupiravir Antiviral COVID Pill
The FDA issued emergency authorization for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults age 18 and older with positive results of direct SARS-CoV-2 viral testing.
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Merck VaxNeuvance Pneumococcal Vaccine Approved in EU
The European Commission approved Merck’s VaxNeuvance (Pneumococcal 15-valent Conjugate Vaccine) for prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
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Success of COVID Antiviral Pills Hinges on Access to Speedy and Accurate Tests
Experts say the success of COVID Antiviral Pills depends on whether high-risk patients will be able to get tested, and then treated, fast enough to make a difference.
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