Novo Nordisk’s Ozempic Gets FDA Approval as Kidney-Disease Treatment
Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
The Financial Express15h
USFDA gives nod to Novo Nordisk’s Ozempic to reduce risk of kidney failure
Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the ...
The Pharma Letter3h
EU’s shortages monitoring platform fully operational
The use of the ESMP will become mandatory for MAHs and NCAs as of Sunday, February 2. The platform is a key requirement of ...
Pharm Exec8h
Treating Disruptive Symptom’s in Crohn’s Patients: Q&A with Mark Genovese, MD
Mark Genovese: Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability, ...
Novo Nordisk secures FDA approval for Ozempic in diabetes with CKD
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks ...
GSK announces EMA accepted for review the MAA for depemokimab
GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indicati ...
PMLiVE7h
Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA
Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides a Corporate Update
Reported a robust objective response rate of 75.5% from the Phase 1 study of NX-5948 in patients with relapsed/refractory CLL/SLL at the 66th ...
Pharmabiz12h
EMA accepts for review regulatory application of GSK’s Shingrix new prefilled syringe presentation for prevention of shingles
EMA accepts for review regulatory application of GSK’s Shingrix new prefilled syringe presentation for prevention of shingles: London, UK Wednesday, January 29, 2025, 13:00 Hrs ...
Pharmabiz16h
EMA accepts for review GSK’s MAA for depemokimab for use in asthma with type 2 inflammation and CRSwNP
EMA accepts for review GSK’s MAA for depemokimab for use in asthma with type 2 inflammation and CRSwNP: London, UK Wednesday, January 29, 2025, 09:00 Hrs [IST] GSK plc announced ...