The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the FDA concerning its BLA for UX111 (ABO-102).

The FDA has accepted MSD’s doravirine/islatravir new drug application (NDA) for review to treat adults with virologically suppressed HIV-1.

The DoH and Children’s National Hospital in the US have signed a MoU to advance paediatric cell and gene therapy.

In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success ...

The Swiss Agency for Therapeutic Products (Swissmedic) has approved Novartis’ Coartem (artemether-lumefantrine) Baby, described as the first malaria medicine for newborns and young infants. Known as ...

Achieving good oral bioavailability for targeted protein degraders (TPDs) is vital in providing a patient-friendly way to ...

Proposals for drug exclusivities and feeble measures to combat drug shortages are unlikely to boost innovation, say some ...

The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.

Swissmedic approved the registration of IFINWIL (eflornithine) as a monotherapy to treat paediatric patients with high-risk neuroblastoma, ...

Transcend Therapeutics announced that the FDA has granted breakthrough therapy designation to TSND-201 to treat PTSD.

Zentiva Group has entered a licence and supply agreement with Lupin for the commercialisation of latter’s biosimilar Certolizumab Pegol.