CDC Issues Alert on Omicron Variant, Provides HCP Recommendations
The CDC is recommending that health care providers take a travel history for all suspected and confirmed cases of COVID-19.
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CDC to Toughen COVID-19 Testing for International Travelers
Not clear whether the new, tougher rule will require an antigen or rapid PCR test
PreHevbrio, a 3-Antigen Hepatitis B Vaccine, Gets FDA Approval
PreHevbrio contains the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface antigens.
Pneumococcal 15-Valent Conjugate Vaccine Gets Priority Review for Pediatric Use
The application is supported by data from phase 2 and phase 3 clinical studies that assessed the efficacy and safety of Vaxneuvance in infants, children, and adolescents.
Negative Allosteric Modulator Gets Fast Track Status for Social Anxiety Disorder
The Company will evaluate BNC210 in patients with SAD in the phase 2 PREVAIL trial.
Lack of Confirmatory Trials Leads to Withdrawal of Multiple Myeloma Treatment
Continued approval required further verification and description of clinical benefit in confirmatory trials.
FDA Panel Votes in Favor of COVID-19 Pill But With Concerns
Molnupiravir is an orally administered form of a ribonucleoside analogue that inhibits the replication of SARS-CoV-2.
November 2021: 5 Notable Drug Approvals
The new approvals include Besremi, Fyarro, Livtencity, Voxzogo, and Vuity.
Colchicine No Benefit Over Supportive Care for COVID-19
No significant reduction reported in mortality, ventilatory support, ICU admission, length of stay, serious adverse events; increase seen in adverse events, diarrhea
ATS: Consider FEɴᴏ Test for Optimizing Asthma Treatment
The use of FENO testing in addition to usual care is suggested for patients with asthma in whom treatment is being considered
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