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The FDA issued a warning letter to active pharmaceutical ingredient (API) manufacturer Vega Life Sciences for violations of good manufacturing practices (cGMP) at its facility in southern India. Read More
A new clinical trial network formed by the National Institute of Allergy and Infectious Diseases (NIAID) aims to accelerate COVID-19 vaccine research by using a standardized protocol to test multiple vaccine candidates, allowing results of the trials to be compared more easily. Read More
Merck and Eisai have received a complete response letter (CRL) from the FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More
Chinese drugmaker Clover Biopharmaceuticals has received a $66 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI) to support clinical development and manufacturing of its candidate COVID-19 vaccine. Read More
The FDA cited Takeda biotech subsidiary Baxalta for a host of violations at its Thousand Oaks, California facility, including GMP lapses that could lead to product contamination. Read More