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 ...

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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. ...

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Lilly announces Health Canada's authorisation of Verzenio (abemaciclib) label expansion

7 December 2023 - Verzenio's label expanded to include the full study population investigated in the Verzenio Phase 3 monarchE trial. ...

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Bristol Myers Squibb's Abecma becomes first CAR T approved for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma in Japan

6 December 2023 - BMS announced today that the company has received manufacturing and marketing approval of the supplemental new ...

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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. ...

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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. ...

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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. ...

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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 ...

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Junshi Biosciences announces new chemical entity application for toripalimab accepted by Australia’s TGA

1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in ...

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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 ...

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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 ...

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Keytruda is a step closer to being available for more cancers listed on the PBS

1 December 2023 - Thousands of cancer patients in Australia will benefit from a major change that would see Keytruda offered ...

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FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma

1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...

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Pembrolizumab with trastuzumab and chemotherapy for the first-line treatment of patients with advanced HER2 positive gastric or gastro-oesophageal junction cancer

1 December 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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FDA grants priority review for supplemental biologics license application of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer

30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...

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