New ‘Breakthrough’ Therapy for Non-CF Bronchiectasis
The US FDA recently granted Breakthrough Therapy Designation to a novel inhaled therapy called CMS I-neb, which is designed to treat non-CF bronchiectasis.
Category: US Pharmaceuticals
US Pharmaceuticals
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US Pharmaceuticals
Latest
FDA Expands Authorization of Pfizer COVID Booster to Kids 5-through-11
Children age 5-through-11 are now authorized to receive the Pfizer COVID booster at least five months after completion of their primary two-dose series of the Pfizer vaccine.
US Pharmaceuticals
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Moderna Developing Bivalent COVID Vaccine Booster
Moderna's first bivalent COVID vaccine booster candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to mRNA-1273 against all variants of concern, including Omicron.
Third COVID Vaccine Increased Immune Response in Multiple Myeloma Patients
A third COVID vaccine dose benefitted most immunocompromised people with a blood cancer called multiple myeloma, according to a fast-tracked study in Cancer Cell.
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Second Booster of Moderna, Pfizer Vaccines Authorized for Adults 50+ and Immunocompromised
The FDA authorized a second booster vaccine from both Moderna and Pfizer/BioNTech for US adults age 50 and older, and certain immunocompromised patients.
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Monoclonal Antibody Sotrovimab No Longer Authorized in Northeastern US
The FDA revoked the emergency use authorization for the monoclonal antibody Sotrovimab in the Northeastern US due to its ineffectiveness against the Omicron BA.2 subvariant.
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Syringes of Symjepi Epinephrine Recalled
Adamis Pharma issued a recall of certain lots of Symjepi (epinephrine) Injection prefilled single-dose syringes due to the potential clogging of the needle preventing the dispensing of epinephrine, according to an FDA alert.
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Losartan Not Effective in Reducing COVID-19 Lung Damage
The common blood pressure medication Losartan is not effective in reducing lung injury in patients with COVID-19, according to research published in JAMA Network Open.
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Moderna Requests FDA Authorization of Second Booster for All Adults
Moderna Inc has submitted a request to the US FDA to allow for a second booster (fourth dose) of its COVID-19 vaccine (mRNA-1273) in all US adults.
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Pfizer/BioNTech Request FDA OK of Second Booster Dose for Seniors
Pfizer and BioNTech have requested FDA authorization of a second booster dose of their COVID-19 vaccine for adults 65 years of age and older.
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FDA Approves First Symbicort Generic to Treat Asthma and COPD
The US FDA approved the first Symbicort generic inhalation aerosol from Mylan Pharmaceuticals for the treatment of asthma and COPD.
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Azithromycin Did Not Prevent Wheeze in Infants with RSV
Among infants hospitalized with respiratory syncytial virus (RSV), there was no difference in the amount of wheezing in babies treated with azithromycin versus those who received a placebo.
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RSV Monoclonal Antibody Nirsevimab Highly Effective in Phase 3 Trial
The investigational long-acting monoclonal antibody Nirsevimab showed 74.5% efficacy against medically attended lower respiratory tract infections caused by RSV in healthy infants.
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More Healthcare Workers Planned to Vaccinate Children Under 5 Compared to Non-HCWs
Fifty-seven percent of parents who are healthcare workers planned to vaccinate their children under age 5 as soon as a vaccine was approved.
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Higher Dose of Ivermectin Tested for Mild-to-Moderate COVID-19
An expanded ACTIV-6 study will test 600 mcg/kg of ivermectin daily for six days in patients who have had a positive COVID-19 test within the past 10 days, and have at least two symptoms of the illness for no more than seven days.
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