As theranostic radiopharmaceuticals gain prevalence, companies must overcome associated regulatory, manufacturing and ...

The FDA's verdict on PTC's Translarna could spell the end for the drug's decades-long and tumultuous US DMD development ...

Lilly’s amassing of a $1.5bn pre-launch inventory follows sizeable investments into US manufacturing facilities.

As drug potency increases, OEB 6 containment is becoming increasingly crucial for safe HPAPI manufacturing, driven by oncology growth, and complex payloads.

Disc Medicine has received a CRL from the US FDA concerning its New Drug Application (NDA) for bitopertin for EPP.