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RSS FeedPosted 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 21 Dec 2024
Gilead submits new drug application to US FDA for twice-yearly lenacapavir for HIV prevention
19 December 2024 - Lenacapavir named 2024 “Breakthrough of the Year” by Science Magazine. ...
Posted by Michael Wonder on 21 Dec 2024
Ultragenyx submits biologics license application to the US FDA for UX111 AAV gene therapy for the treatment of Sanfilippo syndrome type A
19 December 2024 - If approved, UX111 would be the first approved therapy in the US for Sanfilippo syndrome type ...
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 20 Dec 2024
PTC Therapeutics announces vatiquinone NDA submission to FDA for the treatment of children and adults living with Friedreich ataxia
19 December 2024 - PTC's fourth approval application submitted to FDA in 2024. ...
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 19 Dec 2024
Savara initiates rolling submission of a biologics license application to the US FDA for Molbreevi for the potential treatment of auto-immune pulmonary alveolar proteinosis
18 December 2024 - Company expects to complete BLA submission by end of Q1, 2025. ...
Posted by Michael Wonder on 19 Dec 2024
LIB Therapeutics submits a biologic license application to FDA for lerodalcibep for the treatment of adults with elevated LDL-cholesterol
16 December 2024 - Lerodalcibep is a novel, adnectin based, small protein binding, third generation PCSK9 inhibitor. ...
Posted by Michael Wonder on 19 Dec 2024
MAIA Biotechnology granted FDA rare paediatric disease designation for THIO as a treatment for paediatric high grade gliomas
16 December 2024 - MAIA Biotechnology today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high ...
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 18 Dec 2024
Merck announces FDA acceptance of biologics license application for clesrovimab, an investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
17 December 2024 - If approved, clesrovimab has the potential to be available to help address the burden of RSV ...
Posted by Michael Wonder on 18 Dec 2024
Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer
16 December 2024 - Designation based on data showing no evidence of disease in 100% of all 42 patients who completed ...