The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults, a particularly debilitating condition affecting over 70 million patients in Europe. In 2022, Pierre Fabre…
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or…
GSK announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In…
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company’s interchangeable biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases. “With this FDA approval, we are now able…
Prime Medicine, a biotechnology company committed to delivering a new class of differentiated, one-time curative genetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PM359, submitted on March 29,…
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding…
Allergan Aesthetics, an AbbVie company, today announced the launch of two new products from SkinMedica® by the makers of BOTOX® Cosmetic. The SkinMedica® Acne Clarifying Treatment and SkinMedica® Pore Purifying Gel Cleanser are breakthroughs in skincare, providing effective and balanced…
Daiichi Sankyo and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory…
Basilea Pharmaceutica, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the US Food and Drug Administration (FDA) approved ZEVTERA® (ceftobiprole medocaril sodium for injection), for the treatment of…
Voydeya (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is a first-in-class, oral, Factor D inhibitor developed as an…