Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) ...
FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The FDA accepted an NDA for a bictegravir and lenacapavir single-tablet regimen for adults with HIV-1 who have achieved virologic suppression.
The Justice Department announced Wednesday that it had indicted 10 current and former Mexican officials on drug-trafficking ...
As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...
Coramitug is currently being investigated in the phase 3 CLEOPATTRA trial in approximately 1280 patients with ATTR-CM.
The Trump administration launched a bombshell offensive Wednesday against Mexican government officials accused of complicity ...
The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
The U.S. government has charged the governor of Sinaloa and nine other current and former Mexican officials with drug ...
FDA expands Dupixent approval for children aged 2 to 11 years with chronic spontaneous urticaria symptomatic despite H1 antihistamine use.
Breztri Aerosphere is a single-inhaler fixed-dose triple therapy that combines budesonide, glycopyrrolate, and formoterol fumarate.
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