Diana Ernst

The Food and Drug Administration (FDA) has approved Simtriyo ® (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20kg.

Shionogi announces US availability of Xocova ® (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure.

Overall population (cirrhotic and noncirrhotic; N=905): 93.9% vs 94.8%; Patients without cirrhosis (n=721): 93.5% vs 94.6%; and

(ensitrelvir) is now available for postexposure prophylaxis (PEP) of COVID‑19 in adults and adolescents aged 12 years and older following contact with an individual who has COVID-19.

PolyPid announces FDA acceptance of NDA with Priority Review for D-PLEX₁₀₀. News release. PolyPid. July 29, 2026.

Capricor Therapeutics provides update on FDA advisory committee meeting for deramiocel. News release. Capricor Therapeutics. July 30, 2026.

Meitheal Pharmaceuticals announces FDA approval of Garzulys ™ (insulin aspart-fsan) injection. News release. Meitheal Pharmaceuticals. July 30, 2026.

The Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee voted 9 to 3 that the available evidence does not support the effectiveness of deramiocel for the treatment of cardiomyopathy in patients with Duchenne muscular dystrophy (DMD).

Topline results were announced from two phase 3 trials evaluating ritlecitinib in patients with active or stable nonsegmental vitiligo (NSV).

Levacetylleucine for Ataxia-Telangiectasia Zilganersen for Alexander Disease Lirafugratinib for FGFR2+ Cholangiocarcinoma