A Bangladeshi company that would like to sell an antibiotic in the U.K. has been stopped before it started.
A Glenmark plant in Baddi has been cited by the FDA for a variety of problems including questions on the unauthorized destruction of quality records.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
A Sanofi exec defended its dengue shot in the Philippines on Monday as new reports showed local experts had warned against a broad vaccination push.
JLABS lands first ex-North America site in Shanghai, Sanofi's Dengvaxia situation quickly worsens in the Philippines, Astellas buys DMD biotech.
A U.S. unit of Japan’s Daiichi Sankyo that makes sterile injectable drugs will invest $145 million to expand facilities in Ohio, adding 80 jobs in the process…
The Philippines halted its dengue vaccination program after Sanofi flagged serious risks for recipients who'd never been infected with the virus.
Takeda offloaded cancer assets, AstraZeneca formed drug discovery JV in China, Biocon's Herceptin biosimilar plant cleared FDA.
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.
Russian biotech Biocad said it reached a deal with Sothema Labs of Morocco to produce biosimilars rituximab and bevacizumab, used to treat cancer.