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Lipella Pharmaceuticals initiates Phase 2a trial for LP-310 in oral lichen planus, enrolling the first patients

to minimize systemic toxicity. The trial is anticipated to conclude by mid-2025, with top-line data expected year-end 2024. Dr. Michael Chancellor, Chief Medical Officer of Lipella added, “We have heard the urgency for new effective OLP therapies...

NewAmsterdam Pharma announces positive topline data from the Phase 3 BROOKLYN trial of Obicetrapib in heterozygous familial hypercholesterolemia patients

as a fixed-dose combination. The Company began enrolling patients in BROADWAY in January 2022 and in TANDEM in March 2024; completing enrollment of BROADWAY in July 2023, and TANDEM in July 2024. The Company also commenced the Phase 3 PREVAIL...

Innocan Pharma submits Investigational New Animal Drug application to FDA's Veterinary Center.

to pursuing innovative animal drug products and technology and granted the company a sponsor fee waiver for fiscal year 2024. Innocan's LPT-CBD is a proprietary drug delivery platform designed to provide prolonged-release CBD for chronic pain and...

Teva and Sanofi Announce Accelerated Anti-TL1A Phase 2b Program for Inflammatory Bowel Disease

in patient recruitment. As a result, Teva and Sanofi now anticipate having topline results for both UC and CD in Q4 2024, and detailed results will be presented in a scientific forum in 2025. This adjustment replaces the previously planned interim...

Prolacta Bioscience Leads in Human Milk Science, Regularly Reviewing Health Claims with FDA

(FDA), and the agency works with Prolacta, where and if necessary, to refine the claim language. In response to a May 2024 complaint filed by Mead Johnson & Company with the BBB National Advertising Division (NAD) challenging certain advertising...

Mercury Bio's new project includes Los Alamos and the National Center for Genome Resources.

Antibodies, and Enzymes, to a Broad Range of Cell and Tissue Types, at the mRNA Therapeutic Summit in Boston on July 29, 2024. About Mercury Bio: Sparked by scientific breakthroughs in genomic research, Mercury Bio has developed a next-generation...

Cytoki Pharma Announces Positive Phase 1 Data Showing Potential of CK-0045 to Improve Cardiometabolic Risk Factors

further assess the clinical relevance of observed effects. Initiation of the Phase 2 is anticipated in the second half of 2024. About CK-0045: CK-0045 is a long-acting analogue of interleukin-22 (IL-22), an atypical, non-immunomodulatory cytokine...

Nature Study Reveals: AI and Molecular Dynamics Designed BGM0504 Exhibits Superior Potency

receptor agonist, BGM0504, have been published online in Scientific Reports, a sub-journal of Nature, on July 19, 2024. Bright Gene (Stock Code: 688166.SH) is an innovative pharmaceutical company emerging on the international stage, is focused on...

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...

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