Shots:The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitorsBLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…
Shots:The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024 The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2024 The US FDA approved a total of 2 new drugs including 1 new molecular entity and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Eli Lilly’s Kisunla for…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2024 The US FDA approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Ipsen’s Iqirvo for the treatment…
Shots: The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP PharmaShots has compiled…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2024 The US FDA approved a total of 3 new drugs including 2 new molecular entities and 1 biologic leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Amgen’s Imdelltra for the treatment…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2024 The US FDA approved a total of 12 new drugs including 11 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was X4 Pharmaceuticals’ Xolremdi for…

