New influenza and RSV research offers clinically relevant insights into vaccine performance and outbreak prevention. This roundup examines an investigational mRNA flu vaccine, rapid oseltamivir use in...
A systematic review and pooled meta-analysis of 17 RCTs involving 5,500 adolescents and adults found little evidence that very low nicotine content cigarettes increased cigarette consumption or carbon...
July 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA approval introduces a nonprescription fixed-dose combination of 2 widely used analgesics for temporary relief of common minor aches and pains in adults and children aged 12 years or older.
The FDA approved subcutaneous isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis US LLC) for multiple myeloma treatment regimens across relapsed, refractory, and newly diagnosed disease settings.
The FDA expanded approval of exagamglogene autotemcel (Casgevy) for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia.
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The FDA approved gedatolisib with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected after...
The FDA approval provides physicians with a once-daily oral PCSK9 inhibitor option to reduce LDL-C in adults with high cholesterol, including those with heterozygous familial hypercholesterolemia.
The FDA approval expands the use of marstacimab-hncq (Hympavzi; Pfizer Inc.) for routine prophylaxis to prevent or reduce bleeding episodes in additional pediatric and inhibitor-positive hemophilia A and B...
