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Summit Therapeutics announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab

Written by | 16 Sep 2024

Summit Therapeutics Inc. announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab. The data was presented… read more.

FDA Advisory Committee reviewed Imfinzi (durvalumab) for treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results – AstraZeneca

Written by | 3 Aug 2024

The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung… read more.

Phase III CheckMate-73L trial did not meet its primary endpoint in stage III non-small cell lung cancer – BMS

Written by | 17 May 2024

Bristol Myers Squibb announced the Phase III CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell… read more.

European Commission approval for tislelizumab as treatment for non-small cell lung cancer – BeiGene

Written by | 28 Apr 2024

BeiGene, Ltd. announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use…. read more.

European Commission approves Keytruda (pembrolizumab) + chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults – Merck

Written by | 15 Apr 2024

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-containing… read more.

Rigel Pharmaceuticals acquires U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation

Written by | 27 Feb 2024

Rigel Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to acquire the U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation. Gavreto is a once… read more.

Tagrisso (osimertinib) is the first EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting of non-small cell lung cancer – AstraZeneca

Written by | 23 Feb 2024

Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients… read more.

FDA acceptance of U.S. and EU regulatory filings for neoadjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer – BMS

Written by | 12 Feb 2024

Bristol Myers Squibb announced two regulatory acceptances for applications for; i. neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and ii. adjuvant Opdivo for the perioperative treatment of… read more.

FDA acceptance of the PMA application for TTFields therapy for non-small cell lung cancer – Novocure

Written by | 1 Feb 2024

Novocure announced that its Premarket Approval (PMA) application seeking approval for the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of… read more.

CHMP recommends subcutaneous injection of Tecentriq for multiple cancer types – Roche

Written by | 19 Nov 2023

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin). Tecentriq (atezolizumab)…. read more.

Approval from the MHRA for Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small cell lung cancer (NSCLC) with a KRASG12C mutation – Mirati Therapeutics

Written by | 8 Nov 2023

Mirati Therapeutics, Inc. a commercial stage biotechnology company, announced the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for Krazati (adagrasib) as… read more.

European Commission approves Opdivo + chemotherapy for neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1% – BMS

Written by | 16 Jul 2023

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer… read more.

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