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

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

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.

Immunic has announced an oversubscribed private placement of up to $400m, strengthening its move from an R&D-focused organisation into a commercial-stage entity.

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