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Undisclosed tadalafil and sildenafil in a “male enhancement” supplement and lorcaserin — a controlled substance that has been withdrawn from the U.S. market — hidden in a weight-loss supplement, have earned Adam’s Secret USA an FDA warning letter. Read More
The FDA encourages developers of drugs and biological treatments for monkey pox — or mpox — to request a preapplication meeting with the agency, according to a draft guidance released today. Read More
Brand-name drugmakers will have to pay the UK government nearly $4.1 billion this year, a sharp increase from approximately $2.2 billion in 2022. Read More
Marcus Research Laboratory of St. Louis, Mo., was slapped with a nine-observation Form 483 for deficiencies ranging from walls and floors so covered in the facility’s active pharmaceutical ingredient (API) that one investigator’s feet got stuck to the floor, to batch production records missing several key steps. Read More
After a potential carcinogen, Nitroso-STG-19 (NTTP), was found in samples of Merck’s sitagliptin-containing diabetes drugs, the New Jersey drugmaker says it has identified the root cause of the nitrosamine impurity and hopes to fix the issue this year. Read More
Moderna is claiming a phase 3 win based on interim trial data for its investigational mRNA-1345 vaccine targeting respiratory syncytial virus (RSV). Read More
In the ongoing battle of pro-life groups vs. the government on access to the so-called abortion pill, the FDA is pressing a Texas judge to reject a request by anti-abortion groups for a court order withdrawing federal approval for the drug. Read More