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.

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

JCR Pharmaceuticals has signed a licence agreement with Alexion, AstraZeneca Rare Disease, for its proprietary JUST-AAV capsids.

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 ...

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

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

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, ...