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RSS FeedPosted by Michael Wonder on 15 Dec 2023
FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer
15 December 2023 - Today, the FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for ...
Posted by Michael Wonder on 15 Dec 2023
FDA approves belzutifan for advanced renal cell carcinoma
14 December 2023 - Today, the FDA approved belzutifan (Welireg, Merck) for patients with advanced renal cell carcinoma following a ...
Posted by Michael Wonder on 15 Dec 2023
Abbisko Therapeutics announces that US FDA has granted fast track designation for its CSF-1R inhibitor pimicotinib (ABSK021)
13 December 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ...
Posted by Michael Wonder on 14 Dec 2023
FDA grants priority review to Amgen's tarlatamab application for advanced small cell lung cancer
13 December 2023 - FDA target action date is 12 June 2024. ...
Posted by Michael Wonder on 14 Dec 2023
FDA approves eflornithine for adult and paediatric patients with high-risk neuroblastoma
13 December 2023 - Today, the FDA approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and paediatric ...
Posted by Michael Wonder on 12 Dec 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in pancreatic cancer
12 December 2023 - Candel Therapeutics today announced that the US FDA granted fast track designation for its lead investigational adenovirus ...
Posted by Michael Wonder on 11 Dec 2023
Erasca granted FDA fast track designation for pan-RAF inhibitor naporafenib in patients with advanced NRAS mutated melanoma
11 December 2023 - First in class and best-in-class potential in NRAS mutated melanoma and other RAS/MAPK pathway altered solid tumours. ...
Posted by Michael Wonder on 08 Dec 2023
EnGeneIC granted FDA fast track designation for novel armed nanocell drug conjugate pancreatic cancer therapeutic
7 December 2023 - EnGeneIC has achieved a significant milestone with the granting of FDA fast track designation for its ...
Posted by Michael Wonder on 08 Dec 2023
Adaptimmune completes submission of rolling biologics license application to US FDA for afami-cel for the treatment of advanced synovial sarcoma
6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US FDA. ...
Posted by Michael Wonder on 06 Dec 2023
FDA grants priority review of ImmunoGen’s supplemental biologics license application for Elahere (mirvetuximab soravtansine-gynx) in platinum-resistant ovarian cancer
5 December 2023 - Priority review granted with PDUFA date of 5 April 2024. ...
Posted by Michael Wonder on 05 Dec 2023
CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high risk BCG unresponsive non-muscle invasive bladder cancer
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
Posted by Michael Wonder on 05 Dec 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Johnson & Johnson's investigational TAR-200 granted US FDA breakthrough therapy designation for the treatment of high risk non-muscle invasive bladder cancer
4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...
Posted by Michael Wonder on 02 Dec 2023
China’s new cancer drug toripalimab is approved in the US but will cost 30 times more
29 November 2023 - In China, a single dose vial costs US$280 but in the US it will have a wholesale ...
Posted by Michael Wonder on 02 Dec 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with locally advanced or metastatic urothelial cancer
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and ...