Despite the trial failure, Sarepta will still seek full approval of AMONDYS 45 and VYONDYS 53 in DMD from the FDA.

At the European Society for Medical Oncology (ESMO) 2025 event, held in Berlin, Germany, between 17-21 October, Celcuity ...

AbbVie's Rinvoq will have to come up against Pfizer’s prospective and Incyte’s approved JAK inhibitors in the non-segmental ...

While AstraZeneca's gefurulimab offered significant improvements to MG-ADL scores, it was bested by a variety of ...

The company’s stock rose significantly after it announced the full Phase I/II data. Image credit: Lightspring / Shutterstock.com. Intensity Therapeutics’ stock has risen nearly 400% after its oncology ...

Accurately tracking trial initiations has often been a challenge because start dates are not always disclosed or are reported incorrectly. Credit: Ihar Halavach via Shutterstock.com. According to ...

The FDA has introduced a new draft guidance, which aims to expedite and simplify the biosimilar approval process, which commissioner Marty Makary noted could result in “massive cost reductions for ...

The trial will investigate the AK0610 injection for the prevention of RSV infection. Credit: QINQIE99 / Shutterstock.com. Shanghai Ark Biopharmaceutical (ArkBio) has commenced a randomised Phase II ...

Aditya Kotta discussed the biotech funding environment and market trends at OCTSC meeting, in San Diego, California, US. Credits: Athanasios Psimadis / Arena International. The biotech sector has ...

The app helps sites and patients stay synchronised, supporting compliance. Credit: SOMKID THONGDEE/Shutterstock.com. US-based software company Suvoda has launched a unified patient mobile app to ease ...