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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
A structured assessment process can determine compliance for lifecycle process validation.
Technologies advance security efforts for drug supply chain.
October 22, 2021
The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.
EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.
EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.
EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.
October 21, 2021
In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.
Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.
October 19, 2021
The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.
October 15, 2021
The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.
Industry representatives sound off on FDA’s FARS report, released in January this year.