Astellas Pharma’s claudin 18.2-directed cytolytic antibody has been approved by the European Commission (EC) as part of a first-line combination treatment for a subset of gastric cancer patients.

AstraZeneca’s (AZ) Tagrisso (osimertinib) has been approved by the US Food and Drug Administration (FDA) to treat a new subset of lung cancer patients. The epidermal growth factor receptor ...

Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended by the European Medicines Agency’s human medicines committee to treat younger eosinophilic oesophagitis (EoE) patients. The Committee ...

Sanofi has shared positive results from a late-stage study of its investigational BTK inhibitor, tolebrutinib, in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). The ...

The US Food and Drug Administration (FDA) has approved Zevra Therapeutics’ Miplyffa (arimoclomol) to treat Niemann-Pick disease type C (NPC), an ultra-rare lysosomal storage disorder affecting one in ...

The marketeer wants the agency it knows and trusts, not the ones on the list; the agency has spent a fortune on a pitch only to find the budget is a fraction of that suggested and the plan has changed ...

Risk taking is complicated. In business, ebullient entrepreneurs are lauded for putting their livelihood on the line and taking risks, while serial gamblers who do the same are frowned upon. When it ...

Ipsen’s Iqirvo (elafibranor) has been conditionally approved by the European Commission (EC) to treat primary biliary cholangitis (PBC). The oral peroxisome proliferator-activated receptor (PPAR) ...

Pfizer and BioNTech’s updated COVID-19 vaccine targeting the KP.2 strain, a descendant of JN.1, has been recommended by the European Medicines Agency’s human medicines committee for use in individuals ...

Eli Lilly and Almirall have announced positive long-term results for their targeted IL-13 inhibitor Ebglyss (lebrikizumab-lbkz) in moderate-to-severe atopic dermatitis (AD). The ADjoin long-term ...

Traditional information gathering across the pharmaceutical industry, collected directly from healthcare professionals (HCPs), patient registries and regulatory databases, provides insightful ...

The European Commission (EC) has extended the marketing authorisation for Bavarian Nordic’s smallpox and mpox vaccine to include adolescents aged 12 to 17 years. Imvanex (MVA-BN) is already approved ...