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RSS FeedPosted 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 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
ICER publishes fourth annual assessment of barriers to fair access within US commercial insurance prescription drug coverage
19 December 2024 - Most payers evaluated offer fair access across the domains reviewed; findings underscore the need for greater ...
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
Recommendations made by the PBAC – November 2024
20 December 2024 - Recommendations made by the PBAC in November 2024 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 20 Dec 2024
New agreement to ensure medicines stay cheaper and on pharmacy shelves
19 December 2024 - The Australian Government is ensuring medicines stay cheaper and on pharmacy shelves across Australia, through a new ...
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
Lilly's Kisunla (donanemab-azbt) approved in China for the treatment of early symptomatic Alzheimer's disease
17 December 2024 - China is the fourth major market where Kisunla has received approval. ...
Posted by Michael Wonder on 19 Dec 2024
Gilead’s seladelpar receives positive CHMP opinion for primary biliary cholangitis
13 December 2024 - Recommendation based on the RESPONSE study which demonstrated ALP normalisation in 25% of participants at 12 months ...
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
Johnson & Johnson submits application to the EMA seeking approval of a new indication for Imbruvica (ibrutinib) in adult patients with previously untreated mantle cell lymphoma who are eligible for autologous stem cell transplant
18 December 2024 - The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with ...
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 ...