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RSS FeedPosted 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 ...
Posted by Michael Wonder on 12 Jan 2024
European Commission approves Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small-cell lung cancer with a KRAS G12C mutation
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
Posted by Michael Wonder on 10 Jan 2024
Tivdak supplemental biologics license application accepted for priority review by FDA for patients with recurrent or metastatic cervical cancer
9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK ...
Posted by Michael Wonder on 10 Jan 2024
European Commission approves Pfizer’s Talzenna in combination with Xtandi for adult patients with metastatic castration resistant prostate cancer
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
Posted by Michael Wonder on 09 Jan 2024
Sellas Life Sciences receives FDA fast track designation for SLS009 for treatment of relapsed/refractory acute myeloid leukaemia
9 January 2024 - Sellas Life Sciences Group today announced that the US FDA has granted fast track designation to SLS009 ...
Posted by Michael Wonder on 09 Jan 2024
Astellas provides update on zolbetuximab biologics license application in US
8 January 2024 - Astellas Pharma today announced the US FDA issued a complete response letter on 4 January 2024, ...
Posted by Michael Wonder on 05 Jan 2024
ProfoundBio announces rinatabart sesutecan FDA fast track designation for patients with advanced ovarian cancer
5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...
Posted by Michael Wonder on 02 Jan 2024
European Medicines Agency validates Bristol Myers Squibb’s application for repotrectinib for the treatment of locally advanced or metastatic ROS1 positive non-small cell lung cancer and NTRK positive solid tumours
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
Posted by Michael Wonder on 27 Dec 2023
Imaging Biometrics granted FDA fast track
19 December 2023 - Imaging Biometrics is pleased to announce that the US FDA has granted fast track designation for oral ...
Posted by Michael Wonder on 27 Dec 2023
FDA grants fast track designation to Henlius’ EGFR targeting ADC HLX42 for NSCLC patients with disease progression on EGFR targeted therapies
27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR ...
Posted by Michael Wonder on 23 Dec 2023
Patritumab deruxtecan granted priority review in the US for certain patients with previously treated locally advanced or metastatic EGFR mutated non-small-cell lung cancer
22 December 2023 - Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 22 Dec 2023
BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
Posted by Michael Wonder on 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...