Late last month, Pfizer announced its coronavirus vaccine clinical trial results, indicating that a three-dose regimen of the Pfizer-BioNTech vaccine was safe and effective for children older than 6...
According to the FDA’s enforcement report, Nephron Sterile Compounding Center, in Columbia, South Carolina, is recalling 2,158,351 medical products including syringes and bags because of a lack...
Data from a study published in February's CDC Morbidity and Mortality Weekly Report suggest that COVID-19 vaccination during pregnancy provides substantial protection for mother and baby.
This...
Novartis’s Kymriah was granted accelerated FDA approval last week after the drug’s clinical trial results demonstrated an 86% overall response rate and a high level of safety. Patients with...
On Tuesday, the CDC warned Americans about the potential for coronavirus recurrence after using Pfizer’s antiviral drug Paxlovid. CDC officials are not recommending any changes to the ordinary...
Sanofi’s Dupixent received FDA approval for use in people suffering from eosinophilic esophagitis (EoE) after a double-blind, placebo-controlled trial proved the drug effectively reduces...
The FDA announced guidance Thursday that allows manufacturers and distributors of dietary supplements to submit late new dietary ingredient (NDI) notifications if they have failed to do so. Directors...
FDA recently amended the emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine booster to include individuals 5– 11 years of age at least five months after completing the...
FDA recently lifted the clinical hold on Gilead’s investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis...
FDA recently limited the authorized use of Johnson & Johnson's COVID-19 vaccine to include individuals 18 years of age and older for whom other authorized or approved vaccines are not...
FDA recently expanded the approval for COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age and older weighing at least seven pounds.
The agency's decision...
FDA recently accepted AstraZeneca’s biologics license application (BLA) for its anti-CTLA4 antibody, tremelimumab, supporting the indication of a single primary dose of the drug added to Imfinzi...
FDA recently accepted the New Drug Application (NDA) for GSK’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat patients with anemia of chronic kidney...
Today, the FDA is proposing a total ban on flavored cigarettes and cigars, citing their link to increased rates of addiction in young people and their elevated risk of enhanced effects on the...
FDA is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacies provide patient...
FDA recently issued an emergency use authorization (EUA) for the first COVID-19 test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.
Qualified,...
The FDA recently granted priority review for AstraZeneca's Enhertu to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and...
FDA recently lifted the partial hold placed on clinical trials evaluating Gilead’s magrolimab combined with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)...
The World Health Organization (WHO) recently updated the emergency use listing (EUL) for Johnson & Johnson’s COVID-19 vaccine, recommending it as a booster in individuals 18 years of age and...
FDA recently issued draft guidance to enroll more participants from underrepresented racial and ethnic populations in the United States into trials, expanding overall clinical trial...
