PHARMASHOTS NEWSWIRE

Puma Biotechnology Announces Initiation of ALISCA™-Breast1 Phase II Trial of Alisertib in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

22 Nov 2024

Clinical Trials

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of pa

U.S. FDA Accepts Supplemental New Drug Application for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer

22 Nov 2024

Regulatory

Submission based on positive results from the Phase III ARANOTE trial which showed NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer (mHSPC) when compared to

Fresenius Kabi Submits 510(k) Notification for the Aurora Xi Plasmapheresis System Software Version 2.0 with New Nomogram

22 Nov 2024

DigiHealth

Lake Zurich, Ill., November 21, 2024 – Fresenius Kabi, an operating company of Fresenius, announced today it has submitted a 510(k) notification to the U.S. Food and Drug Administration seeking clearance of the Aurora Xi Plasmapheresis System software version 2.0. The Aurora Xi is Plas

Arexvy approval expanded to adults aged 50-59 at increased risk of severe RSV disease in Japan

22 Nov 2024

Regulatory

First RSV vaccine approved in Japan to help protect 50-59 year olds at increased risk due to certain underlying health conditions RSV infections can exacerbate these underlying health conditions and lead to severe outcomes, such as pneumonia, hospitalisation and death1 35 countries, including

Xenetic Biosciences, Inc. Presents Positive Preclinical Data Highlighting the Potential of Co-Administration of DNase I with CAR T Cells in a Murine Model of Melanoma Lung Metastasis

22 Nov 2024

Biotech

November 21, 2024 Data presented at the AACR Special Conference in Cancer Research: Tumor-body Interactions: The Roles of Micro- and Macroenvironment in Cancer Results bolster Company's rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patie

Addressing unmet needs for inherited neuromuscular diseases

22 Nov 2024

M&A

Novartis has acquired Kate Therapeutics to further enhance and strengthen our ongoing efforts to advance gene therapies for patients. Nov 21, 2024 Acquisition of Kate Therapeutics enhances and strengthens Novartis strategic priorities in gene therapy and neuroscience innovation Transactio



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