We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s collaboration with the U.S. Patent Trade Office (USPTO) to bring down barriers that delay generics is off to a good start, according to FDA Commissioner Robert Califf, who points to drug companies’ “gaming tactics” as a major problem. Read More
The analytics firm Clarivate has named 15 drugs that are either likely to achieve blockbuster status or to be game-changers benefiting millions of patients in its report Drugs to Watch 2023. Read More
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tadalafil and sildenafil in a “male enhancement” supplement and lorcaserin — a controlled substance that has been withdrawn from the U.S. market — hidden in a weight-loss supplement, have earned Adam’s Secret USA an FDA warning letter.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biological treatments for monkey pox — or mpox — to request a preapplication meeting with the agency, according to a draft guidance released today.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