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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.

Keytruda + chemotherapy before surgery and continued as a single agent after surgery reduced the risk of event-free survival events by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB NSCLC – Merck Inc

Written by | 7 Jun 2023

Merck known as MSD outside of the United States and Canada, announced positive results from the pivotal Phase III KEYNOTE-671 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, as a… read more.

NICE UK recommends Keytruda with carboplatin and paclitaxel for metastatic squamous non-small-cell lung cancer – Merck Inc

Written by | 27 Feb 2022

NICE (UK): Keytruda (pembrolizumab), from Merck Inc. with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if… read more.

Phase III IMpower010 study of Tecentriq consistent with previous studies in NSCLC and published in The Lancet – Genentech/Roche

Written by | 8 Feb 2022

Genentech/Roche presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS)… read more.

FDA grants Tecentriq sLBA priority review in non-small cell lung cancer – Genentech/Roche

Written by | 21 Aug 2021

Genentech/Roche announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based… read more.

FDA approves Lumakras the first and only targeted treatment for KRAS G12C-mutated locally advanced or metastatic NSCLC – Amgen

Written by | 10 Jun 2021

Amgen has announced that the FDA has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC),… read more.

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