Contrast Agent Gadavist Approved for Use in Cardiac MRI
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis among patients with impaired elimination of the drugs.
All articles by Brian Park, PharmD
WHO Updates List of Essential Medication for 2019
The World Health Organization (WHO) has updated the WHO Model List of Essential Medicines for 2019.
FDA Approves Novel Therapy for Relapsed, Refractory Multiple Myeloma
Continued approval of Xpovio for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Fluorouracil Injection Recalled Due to Glass Particulate
No reports of adverse events have been received at this time, as per the Company.
Biosimilar Zirabev Gets FDA Approval for 5 Types of Cancer
The FDA has approved Zirabev (bevacizumab-bvzr; Pfizer), a biosimilar to Avastin (bevacizumab; Genentech).
ACIP Votes to Expand HPV Vaccination Recommendations
The CDC Advisory Committee on Immunization Practices (ACIP) has voted to expand routine and catch-up HPV vaccination in males through 26 years of age who are inadequately vaccinated.
FDA Rejects Edsivo NDA for Vascular Ehlers-Danlos Syndrome
In the CRL, the FDA stated that the Company will need to conduct an adequate and well-controlled trial to evaluate the efficacy of Edsivo in patients with vEDS.
Symdeko Approved to Treat Younger Cystic Fibrosis Patients
The Food and Drug Administration (FDA) has approved Symdeko (tezacaftor/ivacaftor and ivacaftor; Vertex Pharmaceuticals) for the treatment of patients aged ≥6 years with cystic fibrosis (CF) who are homozygous for the F508del mutation or who have at least 1 mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor. Previously,…
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