FDA Expands Authorization of Moderna, Pfizer Boosters to All Americans 18+
The FDA expanded emergency use for both the Moderna and Pfizer-BioNTech COVID-19 vaccine boosters for all individuals 18 years of age and older.
Category: US Pharmaceuticals
US Pharmaceuticals
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US Pharmaceuticals
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FDA Authorizes Moderna and Janssen Boosters
The FDA authorized single booster doses for the Moderna Inc and Janssen COVID-19 vaccines for certain adults age 18 and older, as well as the use of "mix and match" boosters of differing vaccines.
US Pharmaceuticals
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AstraZeneca Requests Emergency Use for COVID-19 Antibody
AstraZeneca has submitted a request to the FDA for an emergency use authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
Moderna Booster Vaccine Induced Antibody Responses Against Delta Variant
Moderna’s COVID-19 vaccine booster (mRNA-1273 50µg dose level) induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2), according to Phase 2 clinical data reported by the company.
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AstraZeneca Monoclonal Antibody Effective as Preventative Therapy
AZD7442, a monoclonal antibody cocktail against the COVID-19 virus, reduced the risk of symptoms in a study of immunocompromised and chronically ill adults later exposed to the virus by 77%, according to AstraZeneca.
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FDA Approves Pfizer/BioNTech COVID-19 Vaccine for Ages 16+
The US FDA has approved the Pfizer-BioNTech COVID-19 Vaccine (now marketed as “Comirnaty”) for individuals 16 years of age and older — the first COVID-19 vaccine to be approved by the agency.
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Moderna Vaccine Effective for Six Months Against Variants
The majority of individuals vaccinated with the Moderna COVID-19 vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for six months after the second dose.
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Developing a Nasal Mist COVID-19 Vaccine
West Virginia University medical researchers say they’ve developed a nasal mist vaccine against SARS-CoV-2.
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FDA Approves Xyway for Idiopathic Hypersomnia
The FDA approved a new indication for Xywav for idiopathic hypersomnia, an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night’s sleep.
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FDA Authorizes Third Dose of Pfizer, Moderna Vaccines for Immunocompromised Patients
The FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
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FDA OK’s Fast Track Status to mRNA RSV Vaccine
The FDA has granted Fast Track designation to Moderna’s investigational single-dose mRNA-1345 vaccine against the respiratory syncytial virus (RSV) for people over 60 years of age.
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FDA Expands Authorized Use of Regen-Cov as Preventative Treatment
The FDA expanded authorization of Regen-Cov to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination.
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Libtayo plus Chemo Significantly Improved Overall Survival in Advanced NSC Lung Cancer
Adding Libtayo to chemotherapy significantly improved median overall survival in advanced non-small cell lung cancer patients from 13 to 22 months, leading to a 29% reduction in the risk of death, compared to chemotherapy alone.
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mRNA Vaccines Cut COVID-19 Infection Risk by 91% in Fully-Vaccinated People
People who receive mRNA COVID-19 vaccines are up to 91% less likely to develop the disease than those who are unvaccinated, according to a new nationwide study published in the NEJM.
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FDA Approves Prevnar 20 Pneumoccocal Vaccine
The US FDA has approved Pfizer’s Prevnar 20 Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia in adults age 18 and older.
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