The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to its surgical stapler and classified the action as "most serious".

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.

Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The ...

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) for the ...

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency's drug program.

FDA names former pharmaceutical company executive to oversee US drug program FDA's drug center hasn’t had a permanent director since January, when Dr. Patrizia Cavazzoni stepped down days before ...

GSK is seeking FDA approval for Blenrep—in combination with Takeda's Velcade and dexamethaone—to treat adults with multiple myeloma who've received at least one prior line of therapy.

(Reuters) -The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told ...

The other shoe has dropped for Roche’s bid to move Columvi into earlier treatment of diffuse large B-cell lymphoma (DLBCL) in the U.S. The FDA has declined to approve Columvi, in combination ...

FDA names former pharmaceutical company executive to oversee US drug program The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program ...

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. FDA ...

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr. George Tidmarsh is the founder and former CEO of several drugmakers. He was named ...