Officer of Bavarian Nordic. The order from HERA will have no impact on the Company’s overall financial guidance for 2024 but brings the total value of secured contracts close to the lower level of the revenue guidance for the Public Preparedness...
company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius...
MTX-463, with approximately three quarters of the cohorts dosed, and completion of the trial expected by the end of 2024. Additionally, MTX-463 was granted orphan drug and fast track designations by the FDA, underscoring the potential of WISP1 to...
propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing deal will include certain payments, including an upfront payment and milestone payments upon achievement...
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...
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...
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...
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...
(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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
