Sarepta’s DMD drug hit with FDA Complete Response Letter
The company say they are “surprised” to have received the letter.
Read More
Tag: Complete Response Letter
FDA hits Acacia with another rejection, cites manufacturer issues
The same issue was raised initially in October 2018.
Read More
Nabriva hit with FDA rejection of Contempo for complicated urinary tract infections
The company cited issues related to facility inspections and manufacturing deficiencies at one contract manufacturer.
Read More
FDA rejects oral Type I diabetes drug
The FDA has dashed Sanofi’s hopes of launching its type I diabetes drug, Zynquista, this year.
Read More
- MHRA approves new treatment for severe alopecia areata
- Aplagon doses first patient in phase 2a trial of APAC
- NHS to offer fezolinetant for menopause‑related hot flushes and night‑sweats
- UCB reports superiority of bimekizumab in psoriatic arthritis study
- Kainova reports positive results for DT‑9081 in advanced solid tumours
