With clinical trials under pressure, industry leaders say it’s time for reform, digital transformation, and more patient-centric models.

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

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 ...

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

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

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

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 ...

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

IGI Therapeutics has signed an exclusive licensing agreement with AbbVie, for ISB 2001 to treat cancer and autoimmune diseases.

Vetter Pharma, has begun the construction of a new clinical manufacturing facility in Des Plaines, Illinois, US.

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