WHO’s director general described the policy guidelines for Gilead’s twice-yearly drug as the “next best thing” in the absence of a vaccine.

Illimis has completed a Series B funding round, securing $42m for the development of its GAIA-based Alzheimer's disease therapeutics.

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.

BeOne Medicines has secured approval from the EC for Tevimbra (tislelizumab) to be used along with gemcitabine and cisplatin to treat NPC.

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 ...

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 ...