Already dealing with a saline shortage, the FDA now says IV feeding products are scarce after the hurricane damaged plants in Puerto Rico.
Mylan and Biocon today became the first drugmakers to win an FDA approval of a biosimilar of Roche's blockbuster cancer drug Herceptin.
German regulators have signed off on a corrective and preventive action plan for one of Dr. Reddy’s formulation production facilities in India.
Indian drugmaker Dr. Reddy’s said it has been named in a securities class-action lawsuit in the U.S. for alleged violation of federal securities laws.
Gritstone Oncology, which focuses on personalized cancer immunotherapy, opened a new biomanufacturing facility in Pleasanton, CA, to produce the company’s…
Russian biotech Biocad said it reached a deal with Sothema Labs of Morocco to produce biosimilars rituximab and bevacizumab, used to treat cancer.
Bluebird Bio bought a manufacturing site in Durham, North Carolina, as it prepares to bring gene therapies to market over the next four years.
Mumbai-based Glenmark Pharmaceuticals says it received seven observations during an FDA inspection of its Baddi manufacturing plant.
Xellia Pharmaceuticals is hiring at the former Ben Venue Labs in Bedford, Ohio, as it prepares to begin drug manufacturing at the site next year.
With plans for a major expansion of its site North Carolina, Fresenius Kabi's investments aimed mainly at the U.S. generics market now top $5 billion.