FDA vs Fraudulent COVID-19 Products
On March 2, The U.S. Food and Drug Administration (FDA) announced about the beginning of the ‘National Consumer Protection Week,’ to encourage consumers and health…
FDA
COVID-19 Vaccination Program: Pharmacies React
COVID-19 pandemic is still active in the US, and so the COVID-19 vaccination program is fully functioning and still in progress. According to the last…
FDA Issues EUA for Third COVID-19 Vaccine
On February 27, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus…
Duchenne Muscular Dystrophy Mutation Treatment
The U.S. Food and Drug Administration (FDA) recently granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients…
FDA Warns Companies for Selling Dietary Supplements
Recently the U.S. Food and Drug Administration (FDA) announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate,…
Patient Specific Talus Spacer 3D-printed Talus Implant
On the February 17, the U.S. Food and Drug Administration (FDA) approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The Patient…
FDA Approves Cosela
On February 12, the U.S. Food and Drug Administration (FDA) approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of…
Monoclonal Antibodies For Treatment of COVID-19
On the February 9, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab (monoclonal antibodies) administered together for…
Potential Risks Associated With Remdesivir Drug Products
After the approvement of a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients (12 years of age and…
Janssen COVID-19 Vaccine Candidate Discussion
On February 4, it was announced that, The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products…