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.

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

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 ...

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.

Several medical organisations have filed a lawsuit against RFK Jr and the HHS over recent changes to the US immunisation schedule.

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

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 ...

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

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