The U.S. Food and Drug Administration approved Rhythm Pharmaceuticals’ Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.
Genentech’s influenza treatment Xofluza (baloxavir marboxil) was granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the regulatory agency.
The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
AstraZeneca’s Brilinta (ticagrelor) was approved by the U.S. Food and Drug Administration to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack.
Shares of Gilead Sciences Inc. rose after the company’s antiviral drug remdesivir became the first approved treatment for Covid-19 in the United States.
Shares of Gilead Sciences jumped in trading following full approval for Veklury (remdesivir) as a treatment for Covid-19.
The U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The U.S. Food and Drug Administration granted full approval of Genentech’s Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Russia granted regulatory approval to a second Covid-19 vaccine, according to the country’s register of authorized medicines.
Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
