Patients treated with gammaCore experienced clinically meaningful benefits.
This week we have news on pediatric influenza vaccine guidance; Moderna submit data for their COVID-19 booster dose; There’s new FDA warnings for some JAK inhibitors; Trudhesa nasal spray is approved; And the FDA places a clinical hold on a gene therapy for phenylketonuria.
Rilzabrutinib is an oral Bruton tyrosine kinase inhibitor currently in development for a number of immune-mediated diseases.
Vazalore™, a liquid-filled aspirin capsule, has been made available by PLx Pharma. Vazalore was approved by the Food and Drug Administration in March 2021. It is indicated for patients with vascular disease and those with rheumatologic diseases who are candidates for aspirin therapy. The product is designed to improve the absorption of aspirin by targeting…
The first COVID-19 vaccine is fully approved by the FDA, we’ll go into all that that entails and also news regarding booster doses, off-label recommendations, promising antibody treatments and a BLA submission from Moderna for their mRNA vaccine.
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
This week we have significant news on the status of a third COVID-19 vaccine booster dose, as well as news for an encephalitis vaccine, another Jardiance indication, an FDA warning concerning patient wristbands, and Jemperli gets accelerated approval.
Big news on the COVID-19 vaccine booster dose. The CDC issues new recommendations on vaccines. What protection the Moderna vaccine offers after 6 months. A treatment approved for Pompe disease. And the FDA denies an application for a new roxadustat indication.
The FDA authorizes a postexposure prophylaxis for COVID-19; A new treatment is okay’d for lupus; A higher dose naloxone nasal spray became available; The risk evaluation and mitigation program for Clozapine has had important changes, and finally, Istodax has had an indication withdrawn.
This week we have news of the FDA requesting a change to statin prescribing labels, a new vaccine for streptococcus pneumoniae, a new plaque psoriasis cream, a stem cell therapy gets fast tracked as a possible Parkinson disease treatment, and there’s a new treatment approved for Progressive Familial Intrahepatic Cholestasis.
