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 ...

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

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.

Novo and Hims & Hers have continually locked horns over the legality of obesity drug offerings. Hims & Hers has abandoned ...

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

The upcoming patent cliff, the impact of geopolitical and policy issues, and a changing deal environment were discussed at ...

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 ...

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...