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Quality/GMPs

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Manufacturing Process Robustness

A structured assessment process can determine compliance for lifecycle process validation.

Track-and-Trace Progress

Technologies advance security efforts for drug supply chain.

Bristol Myers Squibb Receives European Commission Approval for Opdivo

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.

Trodelvy Gains EMA Nod for Treatment of Aggressive Form of Breast Cancer

October 22, 2021

EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.

EMA Approves Two New Manufacturing Sites and a New Formulation for Comirnaty

October 22, 2021

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA Starts Evaluation of Comirnaty in Children

October 22, 2021

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

FDA Amends EUA to Allow Booster Shots for Moderna, J&J COVID-19 Vaccines

October 21, 2021

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

FDA Highlights Value and Challenges of Advanced Drug Manufacturing

October 21, 2021

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

FDA Approves Cyltezo as Interchangeable Biosimilar with Humira

October 21, 2021

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

FDA Advisory Council Unanimously Supports Johnson & Johnson COVID-19 Booster EUA

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.

FDA Advisory Council Unanimously Supports Moderna COVID-19 Booster EUA

October 15, 2021

The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.

Collecting Industry’s Thoughts on FDA FARS Report

October 15, 2021

Industry representatives sound off on FDA’s FARS report, released in January this year.