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ResQ Pharma receives PDUFA date for LipidRescue™, potentially the first FDA-approved treatment for Local Anesthetic Systemic Toxicity (LAST)

ResQ Pharma, Inc., a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, today announced that it has received a PDUFA (Prescription Drug User Fee Act) date of June 2, 2025, for its LipidRescue Kit. If...

Bracco Diagnostics Inc. reaches one million injections milestone with its MRI agent, VUEWAY® (gadopiclenol)

(Gd) exposure per MRI procedure without compromising image quality. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL is a macrocyclic gadolinium-based contrast agent (GBCA) that offers effective contrast enhancement at half the gadolinium...

SystImmune secures FDA clearance for BL-M17D1 IND in advanced solid tumors

that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology. The IND supports the initiation of a Phase 1...

Transposon to share Phase 2 results of TPN-101 for C9orf72-related ALS/FTD at ALS ONE Research Symposium.

and aging-related diseases, including Alzheimer's disease, announced that results from its Phase 2 study of TPN-101 in patients with amyotrophic lateral sclerosis (ALS) and/or frontotemporal dementia (FTD) related to hexanucleotide repeat expansion...

Aadi Bioscience reports Q3 2024 financial results and updates on corporate progress

available." Recent Operational Highlights: FYARRO net product sales were $7.2 million in the third quarter, an increase of 17 percent from Q2 2024 and 21 percent compared to the prior-year period. This increase is primarily driven by continued...

HanAll Biopharma releases Q3 2024 financial results and shares business updates

of 2024 and provided business updates. HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical sales reached 34...

Cure51 selects 10x Genomics Visium HD to drive its new drug discovery initiative

French TechBio startup Cure51 and 10x Genomics, Inc., a leader in single cell and spatial biology, announced that Cure51 will deploy 10x Genomics' Visium HD as part of its pioneering work to understand the unique biology of exceptional cancer...

GoodRx debuts a new e-commerce platform, starting with Opill®

growth." The GoodRx and Opill partnership addresses significant gaps in healthcare access, particularly for the more than 19 million women living in areas with limited contraceptive services. By removing major obstacles such as high costs and...

Vensica Medical raises $11M to advance Phase 2 trials for its overactive bladder treatment

Vensica Medical a pioneering urology therapeutics company, announced the successful closing of an $11 million funding round. The investment will fund the company's upcoming Phase 2 clinical trials across the United States and Europe for its...

GC Biopharma and Novelty Nobility sign an R&D agreement to develop therapies for geographic atrophy

form of dry AMD that causes damage to retinal tissue, eventually leading to blindness. In the US alone, approximately 1.5 million people are affected by this condition. Last year, the first treatment for GA was approved by the FDA in the US....

BioCryst shares real-world data highlighting strong adherence and persistence with ORLADEYO® (berotralstat)

significant and sustained HAE attack rate reductions after initiating ORLADEYO in patients with HAE, regardless of their C1-inhibitor (C1-INH) deficiency status, and new findings from an HAE patient survey confirming patient preference for an oral...

Great Bay Bio launches its Intelligent Drug Development Ecosystem

On October 18th, the new product launch event hosted by Great Bay Bio (hereinafter referred to as "GBB") was successfully held in Suzhou, where industry players gathered to celebrate the feast of technological innovation. At the event, GBB...

ARTHEx Biotech doses first patient in Phase I-IIa ArthemiR™ trial for Myotonic Dystrophy Type 1

the first participant has been dosed in the Randomized Placebo Controlled Double Blind Phase I-IIa ArthemiR™ Trial of ATX-01 for Myotonic Dystrophy. Type 1 (DM1). DM1 is a devastating rare neuromuscular disorder that causes muscle weakness and...

The U.S. FDA provides positive guidance on the Phase III trial of 64Cu-SAR-bisPSMA for recurrent prostate cancer.

PET/computed tomography (CT) to detect recurrence of prostate cancer. Evaluation will be across 2 imaging timepoints, Day 1 (day of administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging). The...

Aileron Therapeutics will present Phase 1b trial data on low-dose LTI-03 for IPF at the 22nd International Colloquium on Lung and Airway Fibrosis

pulmonary and fibrosis indications, announced the presentation of two abstracts detailing LTI-03's pre-clinical and Phase 1b (NCT05954988) results in Idiopathic Pulmonary Fibrosis (IPF) at the 22nd International Colloquium on Lung and Airway...

Eisai strengthens its presence in Saudi Arabia by establishing a new pharmaceutical sales subsidiary to enhance its operations in the region

Arabia. Eisai Saudi Arabia is a wholly-owned subsidiary of Eisai’s European regional headquarters, Eisai Europe. In the 1960s, Eisai started business in the Middle East marketing and selling Eisai products through local distribution partners. In...

Blue Earth Therapeutics shares positive Phase 1 results for Lutetium (177Lu) rhPSMA-10.1 Injection, advancing its clinical development

further positive developments for its novel investigational radioligand therapies. Enrolment of patients in the Phase 1 trial of Lutetium (177Lu) rhPSMA-10.1 Injection was completed in July. Early data from the trial suggests an encouraging safety...

Prendio-BioProcure presents PrendioPay, simplifying procurement for life science companie

Prendio-BioProcure, a leader in procurement solutions for the life science industry, is excited to launch PrendioPay, an integrated payment platform that evolves the operational reality that most biotech companies face in their business today –...

HNSA-5487 reduced IgG by over 95% in a first-in-human trial, showing redosing potential

Hansa Biopharma AB, announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, the Company's next generation immunoglobulin G (IgG)-cleaving molecule, assessing IgG recovery, immunogenicity and redosing...

Bruker has acquired Dynamic Biosensors, a pioneer in single-cell interaction cytometry systems, aimed at enhancing drug discovery efforts

Bruker Corporation announced the acquisition of Dynamic Biosensors GmbH, a pioneering company known for its breakthroughs in biosensor development, which is based in Munich, Germany. This acquisition strengthens Bruker’s biophysical portfolio for...