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.

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

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

The mRNA therapeutics field is rapidly evolving beyond vaccines to include treatments for cancer, genetic disorders and in vivo cell therapies, bringing with it diverse production challenges. As the ...

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

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

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

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

The US dominates overall sales, yet GlobalData predicts that China is shaping up to be a formidable presence in the cell therapy space.