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RSS FeedPosted by Michael Wonder on 24 Dec 2024
US FDA accepts for priority review Nuvation Bio’s new drug application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer
23 December 2024 - New drug application is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies ...
Posted by Michael Wonder on 24 Dec 2024
Tonix Pharmaceuticals announces PDUFA goal date of 15 August 2025 for FDA decision on US marketing approval for TNX-102 SL for fibromyalgia
23 December 2024 - New drug application based on two statistically significant Phase 3 studies of TNX-102 SL for the ...
Posted by Michael Wonder on 22 Dec 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory Waldenstrom’s macroglobulinaemia
19 December 2024 - Fast track designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenstrom’s macroglobulinaemia. ...
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 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 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
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
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. ...