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China NMPA accepts Astellas’ sBLA for urothelial cancer treatment

The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted Astellas Pharma’s supplemental biologics …

FDA extends review period for Applied Therapeutics’ govorestat NDA

The US Food and Drug Administration (FDA) has announced a three-month extension to the review period for Applied Therapeutics' New …

Intravacc, Primrose to advance conjugate vaccine development

Contract development and manufacturing organisation (CDMO) Intravacc and biotechnology company Primrose Bio have announced a strategic collaboration aimed at bolstering …

EC approves Merck’s KEYTRUDA regimen for NSCLC treatment

The European Commission (EC) has approved Merck’s KEYTRUDA regimen for treating adult patients with resectable non-small cell lung cancer (NSCLC) …

Pharmaceutical compounding companies in contract manufacturing for the pharmaceutical industry

Pharmaceutical compounding has gained popularity as it helps in preparing personalised medications for patients. The individual ingredients are mixed in …