PHARMASHOTS NEWSWIRE

PanTher Therapeutics Receives FDA Clearance of IND Application for Phase 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer

14 Aug 2024

Regulatory

AUSTIN, Texas--(BUSINESS WIRE)--PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced the U.S. Food and Drug Administ

Bayer submits New Drug Application to U.S. FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause

02 Aug 2024

Regulatory

Berlin, August 1, 2024 – Bayer today announced that a New Drug Application (NDA) for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) asso

Health Canada approves Celltrion’s Steqeyma, a biosimilar to Stelara (ustekinumab) for the treatment of multiple chronic inflammatory conditions

02 Aug 2024

Biosimilars

TORONTO--(BUSINESS WIRE)--Celltrion Healthcare Canada Limited today announced that Health Canada has approved Steqeyma® (ustekinumab injection) and Steqeyma® I.V. (ustekinumab for injection, solution for intravenous infusion) for the treatment of moderately to severely active Crohn

BostonGene Announces Partnership with Takeda to Evaluate Immunotherapies Using AI-Powered Molecular Profiling

02 Aug 2024

Pharma

BostonGene, a leading provider of artificial intelligence (AI)-driven molecular and immune profiling solutions, announced that it will collaborate with Takeda on immuno-oncology focused research studies. This partnership aims to identify key molecular drivers and predictive markers for treatment eff

IDeate-Lung02 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Relapsed Small Cell Lung Cancer

02 Aug 2024

Clinical Trials

BASKING RIDGE, N.J. & RAHWAY, N.J., August 1, 2024 – Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the first patient has been dosed in the IDeate-Lung02 Phase 3 trial evaluating the efficacy and safety

US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatm

02 Aug 2024

Regulatory

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary ad



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