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.

Citius Oncology has signed an exclusive distribution agreement with Uniphar to enable access to Lymphir in selected western ...

Outgoing Merck KGaA CEO Belén Garijo is set take the helm at Sanofi, after the French vaccine specialist announced it would not renew existing CEO Paul Hudson’s contract.

The FDA’s refusal to review Moderna's flu vaccine, mRNA-1010, comes within a wider push from the US government to alter ...

Madrigal is eying an expansion of MASH blockbuster Rezdiffra’s capabilities via combination with precision siRNA gene ...

Every two years, South Korea adjusts the national health insurance (NHI) prices for existing listed products based on the ...

The Mexican Government has struck a long-term agreement with Moderna that will see the drugmaker help the country boost its ...