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RSS FeedPosted by Michael Wonder on 30 Dec 2024
Telix files TLX250-CDx (Zircaix) BLA for kidney cancer imaging
30 December 2024 - Telix today announces that it has submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 27 Dec 2024
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
27 December 2024 - Today, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across ...
Posted 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 25 Dec 2024
Glaukos submits new drug application to US FDA for Epioxa
23 December 2024 - Glaukos today announced the submission of its new drug application to the US FDA for Epioxa, its ...
Posted 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
LimmaTech awarded FDA fast track designation for vaccine candidate against Staphylococcus aureus
19 December 2024 - LimmaTech Biologics announced today that the US FDA has granted fast track designation to LimmaTech’s multivalent ...
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 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
BioGenCell receives FDA fast track designation with expanded access for BGC101
19 December 2024 - BioGenCell announced that the US FDA has granted fast track designation to its lead candidate, BGC101, ...
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 ...