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RSS FeedPosted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 23 Jan 2024
Autolus Therapeutics announces acceptance of biologics license application for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukaemia
22 January 2024 - PDUFA goal date is 16 November 2024. ...
Posted by Michael Wonder on 19 Jan 2024
FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
19 January 2024 - Today, the FDA approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic ...
Posted by Michael Wonder on 19 Jan 2024
300 people to benefit from new treatment for advanced breast cancer recommended by NICE following price deal
19 January 2024 - Around 300 people are set to benefit following NICE’s recommendation of talazoparib tosylate for treating a type ...
Posted by Michael Wonder on 18 Jan 2024
Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer
18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...
Posted by Michael Wonder on 18 Jan 2024
New orphan drug for a sub-type of acute myeloid leukaemia: G-BA sees significant additional benefit
18 January 2024 - Since July 2023, there has been one in Germany for patients who suffer from acute myeloid leukaemia ...
Posted by Michael Wonder on 17 Jan 2024
Launch and post-launch prices of injectable cancer drugs in the US: clinical benefit, innovation, epidemiology and competition
17 January 2024 - We aimed to identify and quantify factors associated with launch prices and post-launch price changes of ...
Posted by Michael Wonder on 17 Jan 2024
Olaparib in combination with bevacizumab for the maintenance treatment of adults with advanced high grade epithelial ovarian, fallopian tube or primary peritoneal cancer
17 January 2024 - NICE has published evidence-based recommendations on the use of olaparib (Lynparza) in combination with bevacizumab (Avastin) ...
Posted by Michael Wonder on 17 Jan 2024
European Commission approves Roche’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
16 January 2024 - Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq ...
Posted by Michael Wonder on 16 Jan 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory CLL and SLL
16 January 2024 - Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports ...
Posted by Michael Wonder on 16 Jan 2024
Ono Pharm’s Braftovi for BRAF V600E mutated colorectal cancer gets reimbursement
11 January 2024 - Ono Pharmaceutical Korea said Thursday that Braftovi (encorafenib), a targeted therapy for BRAF V600E mutated metastatic ...
Posted by Michael Wonder on 15 Jan 2024
Durvalumab with cisplatin and gemcitabine hydrochloride for the treatment of patients with unresectable or advanced biliary tract cancer
10 January 2024 - NICE has published evidence-based recommendations on the use of durvalumab (Imfinzi) in combination with cisplatin and ...
Posted by Michael Wonder on 14 Jan 2024
RemeGen's RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients
12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...
Posted by Michael Wonder on 14 Jan 2024
Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer
9 January 2024 - Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 14 Jan 2024
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer
15 January 2024 - On 12 January 2024, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with FIGO 2014 stage ...