PharmTech News

Articles

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

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

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

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

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

EMA Starts Evaluation of Comirnaty in Children

UK government has secured two new antiviral treatments for COVID-19, which may be rolled out in a national clinical study before the end of 2021.

UK Government Announces Deal to Secure Two New COVID-19 Antivirals

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

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

FDA Highlights Value and Challenges of Advanced Drug Manufacturing

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 Johnson & Johnson COVID-19 Booster EUA

The Pharmaceutical Technology and BioPharm International editors host industry experts in serialization and aseptic processing. 

INTERPHEX Keynote Sessions on Wednesday, Oct. 20

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

FDA Advisory Council Unanimously Supports Moderna COVID-19 Booster EUA

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

Can Califf Bring Clarity and Enhanced Credibility to FDA?

AION Labs will be a first-of-its-kind AI/pharma and computational biology innovation lab aimed at spearheading the adoption of AI technologies and computational science. 

Industry News