Management & Regulatory

In the realm of HIV prevention, adherence to a daily regimen has been a formidable barrier for many at-risk individuals. Stigma, low awareness, and daily commitment have undermined the effectiveness of pre-exposure prophylaxis (PrEP) options. Enter Gilead Sciences' Yeztugo, a novel solution

When faced with a rare genetic disorder like hereditary angioedema (HAE), patients often confront an unpredictable and painful journey. Despite advancements in medicine, individuals with HAE experience sudden and recurrent episodes of swelling, which can severely impact their quality of life. The

Imagine a future where cutting-edge medications reach patients in record time. This future is not a distant dream but a tangible possibility thanks to the FDA's introduction of fast-track vouchers under the Commissioner’s National Priority Voucher program. In an era demanding swift responses t

The landscape of medical treatments has experienced a significant development as the FDA has given approval for a new presentation of Celltrion's SteQeyma for pediatric psoriasis and psoriatic arthritis. SteQeyma, an ustekinumab biosimilar referencing Stelara, received authorization for a

In a significant development for cancer treatment, Merck & Co. has received the FDA's approval for Keytruda (pembrolizumab) to be used in a new treatment regimen targeting adults with certain head and neck squamous cell carcinoma (HNSCC). This marks a critical extension of Keytruda's

As temperatures cool and the common cold season descends, a significant health risk may be lurking unnoticed for many younger adults. Respiratory Syncytial Virus (RSV), once considered a pediatric and elderly threat, has raised concerns for adults aged 18 to 59 with underlying health conditions.