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July 2, 2021

FDA Approves New Asparaginase Product for Leukemia FDA Approves New Asparaginase Product for Leukemia

The US Food and Drug Administration (FDA) has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase […]
June 30, 2021

FDA OKs 1-Month Dual Antiplatelet Therapy for Abbott’s Xience Stents FDA OKs 1-Month Dual Antiplatelet Therapy for Abbott’s Xience Stents

The US Food and Drug Administration (FDA) has approved 1-month — as short as 28 days — dual antiplatelet therapy (DAPT) labeling for Xience stents in […]
June 29, 2021

EU Green Light for Roxadustat in Anemia of Kidney Disease EU Green Light for Roxadustat in Anemia of Kidney Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the use of roxadustat (Evrenzo, […]
June 25, 2021

Pfizer Pauses Distribution of Stop-Smoking Pill Chantix Pfizer Pauses Distribution of Stop-Smoking Pill Chantix

Pfizer is suspending distribution of the anti-smoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills. The […]
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 […]
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