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Biotheryx Announces First Patient Dosed in Phase 1 Clinical Trial of BTX-9341

program, BTX-9341, a bifunctional degrader of CDK4 and CDK6, began a Phase 1 clinical trial in the third quarter of 2024. Biotheryx's pipeline also includes BTX-10908, a first-in-class degrader of SOS1 for pan-KRAS mutant cancers and PDE4 degraders...

AusperBio's AHB-137 Receives Breakthrough Therapy Designation for Chronic Hepatitis B Treatment

trials were presented in two late-breaker posters at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy. Bella Lu, Regulatory Affairs Director at AusperBio, underscored that the BTD provides AHB-137 with...

Kedrion Selected by Biotest to Distribute FDA-Approved Immunoglobulin Yimmugo® in the U.S

Subject to finalizing the definitive long-term agreement, Biotest is expected to begin supplying Yimmugo® to Kedrion in Q4 2024, with a market launch planned for Q1 2025. The U.S. IG market is expected to grow by roughly 9% per year in the next...

FDA Grants Second Approval for EPKINLY® (epcoritamab-bysp) to Treat Relapsed or Refractory Follicular Lymphoma

Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for "B-Cell Lymphomas" were recently updated (Version 2.2024) to add EPKINLY as a Category 2A, preferred recommendation for third-line and subsequent therapy for patients with FL. About...

BioMarin to Present Data Showcasing VOXZOGO® (vosoritide)'s Impact on Bone Health and Quality of Life in Achondroplasia

will be presented at the 11th International Conference on Children's Bone Health (ICCBH) in Salzburg, Austria, June 22-25, 2024. BioMarin will also share the first results from a study underscoring the unmet medical needs of people living with...

FDA Accepts sBLA Filing of Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Early Alzheimer's Treatment

subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA in May 2024. Leqembi is now approved in the U.S., Japan, China and South Korea, and applications have been submitted for review in...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

The FDA's approval decision is expected by the Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024. "We are disappointed in today's vote given the urgent unmet need in PTSD and appreciate that the committee faced a...

Thermo Fisher Scientific Introduces Innovative Mass Spectrometer to Advance Clinical Research

Fisher will showcase the Stellar MS at the American Society for Mass Spectrometry (ASMS) annual conference from June 2-6, 2024, in Anaheim, California. The Stellar and Orbitrap Astral mass spectrometers, together with additional new products being...

Bruker Launches Transformative neofleX MALDI-TOF System

MSI immunohistochemistry, neofleX is also compatible with the MALDI-ISH (in situ hybridization) method announced at ASMS 2024 by AmberGen, Inc. MALDI-ISH multiplexes imaging of up to 12 oligomers of interest (RNA/DNA) for multiomic spatial tissue...

Formosa Pharmaceuticals Strikes Licensing Deal with Tabuk Pharmaceuticals for Clobetasol Propionate Ophthalmic Suspension

propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing agreement includes upfront, commercialization milestones, and sales milestones, with additional...

BioLineRx Unveils Poster Presentation on Economic Model Data for APHEXDA® in CD34+ Hematopoietic Stem Cell Mobilization

clinical trials and product labels. The data are expected to be published in Value in Health, Volume 27, Issue 6, S1 (June 2024.) The new economic model data to be presented at ISPOR 2024 builds on the evaluation of APHEXDA for CD34+ HSC...

Regulus Therapeutics Progresses to Cohort 4 in Phase 1b MAD Trial of RGLS8429 for ADPKD Treatment

both topline data from the first cohort of patients in September 2023 and from the second cohort of patients in March 2024. Regulus announced completion of enrollment in the third cohort in January 2024 with patients receiving 3 mg/kg of RGLS8429...

Adcentrx Therapeutics: China NMPA Clears IND for ADRX-0706, a Novel Nectin-4 ADC in Advanced Solid Tumor Treatment

safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects an initial data readout in mid-2024. About ADRX-0706: ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component...

Aurora enhances Australian offerings with premium dried flower range

Australia: MedReleaf Australia is a subsidiary company of Aurora Cannabis Inc., established in 2016 and acquired in 2024. MedReleaf is licensed by the Australian Federal Government's Office of Drug Control (ODC) to cultivate and manufacture medical...

Cold Box Express, Inc. Introduces Refreshed Brand

also coincides with the company’s announcement of a new expanded minimum temperature of -40°C (-40°F), available in summer 2024. About CBX: CBX has been a leading provider of active temperature-controlled solutions for ground transportation of...

Factor Bioscience to Deliver Seven Presentations at the American Society of Gene & Cell Therapy

Therapy. Factor will deliver seven presentations, representing the company's most expansive presentation of data to date. "2024 marks the fifth year that Factor will present our latest data at the Annual Meeting of the ASGCT," said Dr. Matt Angel,...

Algiax Pharmaceuticals expands AP-325 study in chronic neuropathic pain, adds 12 sites in Belgium and France

our efforts to present topline efficacy readouts and an in-depth safety analysis following study conclusion in Q4 2024." About AP-325: AP-325 is a unique small molecule designed to act as a positive allosteric modulator of the GABAA receptor in the...

ProteoNic unveils Early Access Program, boosting viral vector titers with LV-2G UNic® technology

groundbreaking vector technology designed to revolutionize viral vector production. With the official launch on March 20, 2024, ProteoNic extends a warm invitation to CDMOs, biotechs, and biopharmaceutical companies to experience firsthand the...

Sapience Therapeutics to Present Multiple Posters at the American Association for Cancer Research

therapeutics to address oncogenic and immune dysregulation that drive cancer, announced three poster presentations at the 2024 American Association for Cancer Research (AACR). Sapience will present non-clinical immunotherapy results at AACR from...

HemoSonics' Quantra® Hemostasis System

announced that its Quantra Hemostasis System with QPlus® and QStat® Cartridges has been named a finalist in the 2024 Edison™ Awards. The company was honored in the health, medical, and biotechnology category for its Quantra Hemostasis System. The...

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