FDA Revises Letter of Authorization for the Emergency Use Authorization for Paxlovid
January 29, 2024 -- In December 2021, FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 29, 2024 Category: Pharmaceuticals Source Type: clinical trials

First Patient Enrolled in Rise Therapeutics' Rheumatoid Arthritis Clinical Trial
ROCKVILLE, Md., Jan. 29, 2024. Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 29, 2024 Category: Pharmaceuticals Source Type: clinical trials

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Conditions: Chronic Spontaneous Urticaria Interventions: Biological: LP-003; Biological: Placebo; Biological: Omalizumab Sponsors: Longbio Pharma Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 29, 2024 Category: Research Source Type: clinical trials

Vergent Bioscience Presents Phase 2 Data Showing VGT-309 Visualizes Tumors in the Lung During Surgery
MINNEAPOLIS, Minn., January 28, 2024 – Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced new data presented today at the 60th Annual Meeting of The Society of Thoracic... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 28, 2024 Category: Pharmaceuticals Source Type: clinical trials

Nanoform Announces Important Milestone with Promising Clinical Results for Patient-Centric Nanotechnology-Enhanced Enzalutamide
HELSINKI, Jan. 26, 2024. Nanoform Finland Plc ( " Nanoform " ), the medicine performance-enhancing company, today announced that one of its leading nanoformulation drug products had received promising clinical results. These were from a relative... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 26, 2024 Category: Pharmaceuticals Source Type: clinical trials

A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
Conditions: Dry Eye Disease Interventions: Drug: TL-925; Other: Placebo Sponsors: Telios Pharma, Inc. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 26, 2024 Category: Research Source Type: clinical trials

Early Detection of Triple Negative Breast Cancer Relapse
Conditions: Triple Negative Breast Cancer Interventions: Diagnostic Test: ctDNA monitoring; Diagnostic Test: 68Ga-FAPI-46-PET-CT Sponsors: Institut Curie; National Research Agency, France; Roche Pharma AG Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 26, 2024 Category: Research Source Type: clinical trials

FDA Agrees to Amend Special Protocol Assessment for Clinical Trial of AXPAXLI in Wet AMD
BEDFORD, Mass., Jan. 25, 2024 . Ocular Therapeutix, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 25, 2024 Category: Pharmaceuticals Source Type: clinical trials

Vera Therapeutics Presents Positive 72-Week Data Showing eGFR Stabilization in the Phase 2b ORIGIN Clinical Trial OLE in IgA Nephropathy
Participants treated with atacicept for 72 weeks showed consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with stable eGFR over the duration of treatment Placebo cohort participants who crossed over to atacicept 150 mg in the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 25, 2024 Category: Pharmaceuticals Source Type: clinical trials

Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
Conditions: Relapsed/Refractory Large Granular T Lymphocytic Leukemia Interventions: Drug: Linperlisib Sponsors: Institute of Hematology& Blood Diseases Hospital, China; YL-Pharma Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 25, 2024 Category: Research Source Type: clinical trials

Ensysce Biosciences Announces FDA Breakthrough Therapy Designation Granted for PF614-MPAR
SAN DIEGO, CA / ACCESSWIRE / January 23, 2024 / Ensysce Biosciences, Inc. ( " Ensysce " or the " Company " ) (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced receipt of notice... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 23, 2024 Category: Pharmaceuticals Source Type: clinical trials

Glyceryl Eicosapentaenoate Based Topic Products as an Irritant-free Cream and Serum for Hydration of Sensitive Skin
Conditions: Skin Dryness Interventions: Other: Glyceryl Eicosapentaenoate serum; Other: Glyceryl Eicosapentaenoate Cream A; Other: Glyceryl Eicosapentaenoate Cream B; Other: Glyceryl Eicosapentaenoate Cream C Sponsors: SCF Pharma; Institut de recherche clinique du littoral (IRCL) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 23, 2024 Category: Research Source Type: clinical trials

Positive Phase 1/2 Clinical Trial Data for an Investigational Gene Therapy for Genetic Hearing Loss to be Presented at the Association for Research in Otolaryngology 2024 MidWinter Meeting
Hearing restoration was observed within 30 days of a single administration of AK-OTOF in the initial AK-OTOF-101 study participant, the first to receive gene therapy in the United States for a genetic form of hearing loss AK-OTOF is a gene... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 23, 2024 Category: Pharmaceuticals Source Type: clinical trials

Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects
Conditions: Tardive Dyskinesia; Huntington Disease Interventions: Drug: LPM3770164 sustained release tablet; Drug: LPM3770164 sustained release tablet simulant Sponsors: Luye Pharma Group Ltd. Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 22, 2024 Category: Research Source Type: clinical trials

Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Progressive Multiple Sclerosis
EMERYVILLE, Calif., Jan. 19, 2024. Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced it received... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 19, 2024 Category: Pharmaceuticals Source Type: clinical trials