VERTANICAL announced that Exilby® (VER-01) has received marketing authorization in Germany for the treatment of chronic low back pain with a radicular (neuropathic) component. The authorization marks a major milestone for VERTANICAL and highlights...
SQ Innovation, developer of Lasix® ONYU, announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, and the acceptance of Lasix ONYU by the European...
Cellenkos®, Inc., a clinical-stage biotechnology company, developing allogeneic, tissue-targeted regulatory T cell (Treg) therapies, today announced the receipt of U.S. Food and Drug Administration (FDA) clearance to initiate CK0801 Phase 2...
Merck known as MSD outside of the United States and Canada, and Eisai today announced the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG® (belzutifan). Merck’s first-in-class oral...
Astellas Pharma U.S., Inc. announced the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or...
Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation System (SNS), a wireless, implantable brain-computer interface designed for closed-loop treatment of memory disorders. The...
Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and...
Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, announced a strategic collaboration with U.S. Heart and Vascular® (USHV),...
Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced new and updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib) for...
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...
Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...
Alafair Biosciences, Inc., a leading innovator in medical device technology, is pleased to announce the first patient enrolled at UC Davis Foot and Ankle Orthopaedics Clinic, as part of a prospective, multi-center, controlled case series...
Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...
Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...
Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....
Rein Therapeutics a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the RENEW Phase 2 trial of its lead asset,...
Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AISA-021(cilnidipine), a fourth-generation calcium channel antagonist. Aisa is...
Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...
Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory diseases, announced that the first patient has been dosed in its...
