Joseph Keenan

India’s Jubilant Generics and Contract Pharmaceuticals Limited Canada were each hit with Form 483s by the FDA following inspections that uncovered questionable manufacturing practices.

The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping.

The Africa CDC responded to Moderna’s plans to step back from building a mRNA vaccine manufacturing facility in Kenya, saying the move by the Spikevax maker only "perpetuates" the inadequate respon

Dr. Reddy's issued a voluntary recall of six lots of sapropterin dihydrochloride powder used to treat phenylketonuria (PKU) due to potential potency

Samsung Biologics, the giant South Korea-based CDMO, reported an all-time earnings high in the first quarter of this year.

Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth

The FDA, which issued India’s Laurus Synthesis a Form 483 in January, followed up the action with an "untitled letter" (PDF)

The FDA recently hit Dr. Reddy's with a pair of Form 483s following inspections at two of the drugmaker's manufacturing sites located in India.

Stocks of cisplatin are now able to meet demand for the widely used chemotherapy drug that had been in short supply in the U.S. over the last year, the FDA's top official said.

Evotec's biologics manufacturing unit, dubbed Just – Evotec Biologics, has expanded its multiyear biosimilar deal with Sandoz that the partners initially inked in May 2023.