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RSS FeedPosted by Michael Wonder on 26 Dec 2024
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients as young as 2 years old
20 December 2024 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to ...
Posted by Michael Wonder on 26 Dec 2024
FDA approves first generic of once daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes
23 December 2024 - Today, the US FDA approved the first generic referencing Victoza (liraglutide injection) 18 mcg/3 mL, a ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval of Alyftrek, a once daily next in class CFTR modulator for the treatment of cystic fibrosis
20 December 2024 - In head to head clinical trials, Alyftrek was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include additional non-F508del Trikafta responsive variants
20 December 2024 - Approximately 300 more people with cystic fibrosis in the US are now eligible for a medicine ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves first medication for obstructive sleep apnoea
20 December 2024 - Today, the US FDA approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnoea ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves first acellular tissue engineered vessel to treat vascular trauma in extremities
20 December 2024 - The US FDA approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as ...
Posted by Michael Wonder on 22 Dec 2024
FDA approves Alhemo injection as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B with inhibitors
20 December 2024 - FDA approval is based on data from the pivotal Phase 3 trial (explorer7) establishing the safety and ...
Posted by Michael Wonder on 21 Dec 2024
Lexicon announces receipt of complete response letter for Zynquista (sotagliflozin)
20 December 2024 - Confirms previously disclosed and anticipated FDA decision. ...
Posted by Michael Wonder on 20 Dec 2024
FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation
20 December 2024 - Today, the FDA granted accelerated approval to encorafenib (Braftovi, Array BioPharma) with cetuximab and mFOLFOX6 for ...
Posted by Michael Wonder on 20 Dec 2024
Tryngolza (olezarsen) approved in US as first ever treatment for adults living with familial chylomicronemia syndrome as an adjunct to diet
19 December 2024 - Tryngolza shown to significantly reduce triglycerides and substantially reduce acute pancreatitis events in adults with familial chylomicronaemia ...
Posted by Michael Wonder on 20 Dec 2024
US FDA issues complete response letter for the glepaglutide new drug application for the treatment of short bowel syndrome
19 December 2024 - The FDA concluded that Zealand Pharma’s application did not meet the full requirements for substantial evidence to ...
Posted by Michael Wonder on 19 Dec 2024
FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in paediatric patients
18 December 2024 - Today, the FDA approved remestemcel-L-rknd (Ryoncil, Mesoblast), an allogeneic bone marrow derived mesenchymal stromal cell therapy, ...
Posted by Michael Wonder on 18 Dec 2024
FDA approves ensartinib for ALK positive locally advanced or metastatic non-small cell lung cancer
18 December 2024 - Today, the FDA approved ensartinib (Ensacove, Xcovery) for adult patients with anaplastic lymphoma kinase (ALK) positive ...
Posted by Michael Wonder on 18 Dec 2024
US FDA approves Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab)
17 December 2024 - Steqeyma is expected to be marketed in the US in February 2025. ...
Posted by Michael Wonder on 16 Dec 2024
FDA approves Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
16 December 2024 - In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on Vtama cream ...