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IMUNON announced the acceptance of a late-breaking presentation featuring new clinical data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational therapy for the treatment of advanced ovarian [...]

Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries (TEVA), announced that the U.S. Food and Drug Administration, FDA, has approved SELARSDI in a new presentation, 130 [...]

LENZ Therapeutics announced that the U.S. Food and Drug Administration, FDA, has accepted the Company's New Drug Application, NDA, for LNZ100 for the treatment of presbyopia, a condition impacting an [...]

Unicycive Therapeutics announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers. 'We are pleased to announce the successful completion of the UNI-494 Phase 1 study that [...]

Xspray Pharma AB (publ), a pharmaceutical company leveraging its proprietary HyNap technology to develop enhanced cancer therapies, reported significant progress following a productive meeting with the U.S. Food and Drug [...]

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop for the treatment of acid reflux, a treatment field [...]

CERo Therapeutics announced that existing investors have committed a financing of $1.25M. With these funds the Company plans to work with the U.S. Food and Drug Administration to resolve the [...]

Capricor Therapeutics announced, following recent meetings with the U.S. Food and Drug Administration, its intent to file a Biologics License Application, BLA, based on existing cardiac and natural history data [...]

The U.S. Food and Drug Administration is alerting patients, caregivers, health care providers, and health care facilities about the increased risk of thigh bone fracture after surgery with the use [...]

Ainos announced that its plans to initiate a clinical study for very low-dose interferon alpha on treating Human immunodeficiency virus -related oral warts at the National Taiwan University Hospital. The [...]

BriaCell Therapeutics has received feedback from its Pre-IND meeting with the U.S. Food and Drug Administration, which is a step forward to opening an IND to conduct a Phase 1/2 [...]

Silo Pharma announced the completion of a pre-Investigational New Drug meeting with the U.S. FDA regarding the company's development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder [...]

Diamyd Medical will pursue an accelerated approval pathway in the US for its antigen-specific immunotherapy, Diamyd (rhGAD65/alum), aimed at preserving endogenous insulin production in patients with stage 3 type 1 [...]

KalVista Pharmaceuticals, Inc., reported that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the [...]

T2 Biosystems provided an update on its new product development pipeline progress. The Company's product pipeline is focused on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, [...]

Immuron has received favourable feedback from the United States Food and Drug Administration on the pre-IND information package to support the clinical development of IMM-529. Following the FDA's guidance and [...]

SpringWorks Therapeutics announced that the U.S. FDA has accepted the company's New Drug Application for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis [...]

Lykos Therapeutics is cutting 75% of staff after FDA rejected its MDMA drug for mental health. The FDA's decision marks the first time the agency considered a psychedelic for medical [...]

Viracta Therapeutics reported positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the relapsed or refractory (R/R) Epstein-Barr virus-positive peripheral T-cell lymphoma cohort. Additionally, the Company received [...]

Reports Q2 revenue $2.17M, consensus $2.49M. 'Our immediate priority is to finalize the design of our planned pivotal Phase 3 trial of larsucosterol in alcohol-associated hepatitis,' stated James Brown, D.V.M., [...]

Cybin announced that it held a Type B Initial Breakthrough Therapy Meeting with the U.S. Food and Drug Administration late last week in Washington, D.C. The company plans to initiate [...]

Lykos Therapeutics (Lykos), a company dedicated to transforming mental healthcare, announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug [...]

Lykos Therapeutics announced last night that the Food and Drug Administration issued a complete response letter for the new drug application for midomafetamine capsules for the treatment of post-traumatic stress [...]

Kura Oncology announced clearance by the U.S. Food and Drug Administration, FDA, of the Investigational New Drug, IND, application for ziftomenib, the Company's potent and selective menin inhibitor, for the [...]

Rezolute announced that it received U.S. Food and Drug Administration, FDA, clearance for its Investigational New Drug, IND, application for RZ358 to treat hypoglycemia in patients with tumor hyperinsulinism. The [...]

Eyenovia, Inc., a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in paediatric progressive myopia, announced that it has entered into a collaboration agreement with Senju Pharmaceutical [...]

Eyenovia announced that it has entered into a collaboration agreement with Senju Pharmaceutical, under which both companies intend to work to develop Senju's corneal epithelial wound healing candidate, SJP-0035, for [...]

AEON Biopharma, Inc, a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced plans to advance a single pivotal clinical development [...]

Clene and its wholly owned subsidiary Clene Nanomedicine announced plans to submit a briefing book by July 13 to the U.S. Food and Drug Administration in advance of a granted [...]

Can-Fite BioPharma has submitted an application to the U.S. Food and Drug Administration for Orphan Drug Designation for its drug candidate Namodenoson in the treatment of pancreatic carcinoma. Can-Fite plans [...]

Adicet Bio, a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) [...]

The US Food and Drug Administration (FDA) issued a draft guidance, 'Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,' to assist medical product sponsors [...]

Checkpoint Therapeutics reached alignment with the Food and Drug Administration on its biologics license application resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission [...]

Adicet Bio announced that the U.S. Food and Drug Administration, FDA, has cleared the Company's Investigational New Drug, IND, application to evaluate ADI-270, an armored allogeneic 'off-the-shelf' gamma delta chimeric [...]

CorMedix announced that the U.S. Food and Drug Administration has provided feedback to the Company's request to discuss development plans for additional indications for DefenCath. The FDA provided supportive feedback [...]

Capricor Therapeutics announced the completion of a Type-B meeting with the U.S. Food and Drug Administration on next steps for the Biologics License Application submission with its lead asset, CAP-1002 [...]

Adicet Bio, Inc, a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, announced the US Food and Drug Administration (FDA) [...]

CERo Therapeutics Holdings announces the successful completion of toxicology studies for its lead compound, CER-1236. The toxicology studies will be included in the Investigational New Drug Application, IND, package the [...]

Adicet Bio nnounced the U.S. Food and Drug Administration FDA has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. [...]

Nexalin Technology announces that the U.S. Food and Drug Administration has provided feedback and reached consensus on the design for its planned clinical studies in anxiety and insomnia for its [...]

Oneness Biotech Co., Ltd. developed Bonvadis for chronic wound treatment and obtained 510(K) approval for acute wounds. They are currently applying for 510(k) approval for chronic wounds and plan to [...]

VYNE Therapeutics announced the clearance of its Investigational New Drug application, IND, by the U.S. Food and Drug Administration for VYN202, an oral BD2-selective BET inhibitor. VYNE plans to initiate [...]

Byline: admin CVS and Walgreens said they've received certification to dispense mifepristone, a pill that's part of a regimen for medication abortion, and will start making the medicine available in [...]

BioXcel Therapeutics announced details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company's investigational proprietary, orally dissolving film formulation of dexmedetomidine, as [...]

Nexalin Technology has completed the first full production test run and successfully performed usability, feasibility design verification, and electrical safety testing for its new Gen-3 HALO Clarity 15 milliamp neurostimulation [...]