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FDA approves Lumakras (sotorasib) in combination with Vectibix (panitumumab) for chemorefractory KRAS G12C- mutated metastatic colorectal cancer – Amgen

Written by | 31 Jul 2025

Amgen announced that the FDA has approved Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as… read more.

DESTINY-Gastric05 Phase III Trial of Enhertu (trastuzumab deruxtecan) initiated in patients with previously untreated HER2 Positive advanced gastric cancer – Daiichi Sankyo

Written by | 30 Jul 2025

The first patient has been dosed in the DESTINY-Gastric05 phase IIII trial evaluating Enhertu (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine) and Merck’s  anti-PD-1… read more.

Long-term efficacy and safety of Eylea 8 mg (aflibercept 8 mg) with extended dosing intervals in wet age-related macular degeneration confirmed at three years – Bayer

Written by | 29 Jul 2025

Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD) at… read more.

Arexvy recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus disease by US Advisory Committee on Immunization Practices – GSK

Written by | 28 Jul 2025

GSK plc announced that the Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of RSV vaccines including GSK’s Arexvy (Respiratory Syncytial Virus Vaccine,… read more.

Enhertu (trastuzumab deruxtecan) supplemental New Drug Application submitted in Japan for patients with HER2 positive metastatic solid tumors – Daiichi Sankyo

Written by | 27 Jul 2025

Daiichi Sankyo  has submitted a supplemental New Drug  Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Enhertu (trastuzumab deruxtecan) for the treatment of adult… read more.

Positive CHMP opinion for CAR T Cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory follicular lymphoma – BMS

Written by | 26 Jul 2025

Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen… read more.

FDA accepts revised appliction of Izervay (avacincaptad pegol) that aims to add positive two-year clinical trial data to the drug’s label – Astellas

Written by | 25 Jul 2025

Astellas Pharma said that the FDA has accepted for review a revised application for its complement C5 inhibitor Izervay (avacincaptad pegol) that aims to add positive two-year clinical… read more.

Leqembi (lecanemab) is the first medicine that slows progression of early Alzheimer’s disease to be authorized in the EU – Eisai + Biogen

Written by | 24 Jul 2025

Eisai Co., Ltd. and Biogen Inc. announced that the European Commission (EC) has granted the amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) Marketing Authorization (MA) in the European Union… read more.

Tecartus demonstrates high response rate in adults with relapsed or refractory B-cell acute lymphoblastic leukemia – Kite/Gilead

Written by | 23 Jul 2025

Kite, a Gilead Company announced results from the primary analysis of ZUMA-3, a global, multicenter, single-arm, open-label Phase 1/II study evaluating its chimeric antigen receptor (CAR) T-cell therapy… read more.

NICE (UK) terminated appraisal for Tevimbra (tislelizumab) in combination for untreated advanced non-small-cell lung cancer – BeiGene

Written by | 22 Jul 2025

NICE is unable to make a recommendation on tislelizumab (Tevimbra) in combination for untreated advanced non-small-cell lung cancer in adults. This is because the company did not provide… read more.

NICE (UK) positive for Iqirvo (elafibranor) for previously treated primary biliary cholangitis when used with UDCA; or alone, if UDCA cannot be tolerated – Ipsen

Written by | 21 Jul 2025

NICE (UK): 1.1 Elafibranor is recommended, within its marketing authorisation, as an option for treating primary biliary cholangitis in adults, when used: i) with ursodeoxycholic acid (UDCA), if… read more.

FDA grants priority review for new indication of finerenone for patients with heart failure and with a left ventricular ejection fraction of ≥40% – Bayer

Written by | 20 Jul 2025

Bayer announced that the FDA has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for finerenone for the treatment of adult patients with heart… read more.

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