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June 22, 2021

FDA Approves OTC Antihistamine Nasal Spray FDA Approves OTC Antihistamine Nasal Spray

The US Food and Drug Administration (FDA) has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal […]
June 18, 2021

FDA Approves StrataGraft for Deep Skin Burns FDA Approves StrataGraft for Deep Skin Burns

The US Food and Drug Administration (FDA) has approved a novel regenerative therapy that could be an alternative to autografting for treating adults with severe burns. […]
June 17, 2021

Supreme Court Upholds Affordable Care Act Supreme Court Upholds Affordable Care Act

The US Supreme Court upheld the Affordable Care Act Thursday in a 7-to-2 vote, rejecting claims by the challengers that the requirement for all Americans to […]
June 14, 2021

FDA Approves 20-Valent Pneumococcal Vaccine (Prevnar) FDA Approves 20-Valent Pneumococcal Vaccine (Prevnar)

The FDA has approved a novel pneumococcal 20-valent conjugate vaccine capable of protecting against 20 serotypes implicated in most cases of invasive pneumococcal disease (IPD) and […]
June 14, 2021

FDA Recalls More Metformin Extended-Release Tablets FDA Recalls More Metformin Extended-Release Tablets

Two lots of metformin HCl extended-release tablets have been recalled by Viona Pharmaceuticals because unacceptable levels of nitrosodimethylamine (NDMA), a likely carcinogen, were found in the […]
June 11, 2021

EMA Seeks More Data on Myocarditis After COVID-19 Shots EMA Seeks More Data on Myocarditis After COVID-19 Shots

The European Medicines Agency (EMA) safety committee is continuing its review of myocarditis and pericarditis following vaccination with COVID-19 vaccines. “Currently, further analysis is needed to […]
June 11, 2021

EMA Says Sinus Bradycardia a Possible Risk With Remdesivir EMA Says Sinus Bradycardia a Possible Risk With Remdesivir

Following a safety review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended adding sinus bradycardia to the product label for […]
June 11, 2021

EMA Warns of New AZ Vaccine Side Effect EMA Warns of New AZ Vaccine Side Effect

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Following a safety review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the […]
June 8, 2021

FDA Clears Next-Generation DBS System for Movement Disorders FDA Clears Next-Generation DBS System for Movement Disorders

The US Food and Drug Administration (FDA) has approved Medtronic’s technologically advanced deep brain stimulation (DBS) system designed to more precisely target motor symptoms in Parkinson’s […]
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