FDA Calendar

Vertex Pharmaceuticals announced positive longer-term data for PrCASGEVY® (exagamglogene autotemcel) from global ongoing pivotal clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).

Clearmind Medicine Inc. announced that it has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD).

MIRA Pharmaceuticals, Inc. announced positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation.

BioAtla, Inc today presented first-in-human data in a poster titled "Preliminary Results from a First-in-Human Phase 1 Study of a Dual-Conditionally Binding CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager, BA3182, in Patients with Treatment Refractory Metastatic Adenocarcinoma" at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress being held in Barcelona, Spain from July 2–5, 2025.

OS Therapies announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration ("FDA") to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.

Novartis announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA).

4D Molecular Therapeutics announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration (wet AMD).

Inventiva announces the publication in Journal of Hepatology Reports, a peer-reviewed, scientific journal, of results from the Phase 2b NATIVE clinical trial and preclinical study evaluating the effects of lanifibranor on liver sinusoidal endothelial cells in Metabolic dysfunction-associated steatotic liver disease ("MASLD") and MASH.

I-Mab announced the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO).

Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.

Inspira™ Technologies OXY B.H.N. Ltd. announced it has secured a binding $22.5 million purchase order for its FDA-cleared ART100 system, representing a major commercial inflection point for the Company.

Cerus Corporation announced a European regulatory update on the INTERCEPT RBC program.

VYNE Therapeutics Inc today provided a program update for VYN202 following the clinical hold issued by the U.S. Food and Drug Administration (FDA) in April for the Company's Phase 1b clinical trial in the treatment of moderate-to-severe plaque psoriasis.

Organon announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint.

Tonix Pharmaceuticals Holding Corp announced the publication of a paper entitled, "A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis,"1 in the peer-reviewed journal Cancer Cell, that represents a collaboration between scientists at Tonix and Columbia University's Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer.

CytoSorbents Corporation today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada.

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events.

Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for AXN-2510 ("'2510") by the U.S. Food and Drug Administration.

Belite Bio, Inc announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD).

Alpha Cognition Inc announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI).

Cue Biopharma, provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series.

BioXcel Therapeutics, Inc. announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia.

Mustang Bio Receives FDA Orphan Drug Designation For MB-101 Treatment Of Malignant Glioma

RedHill Biopharma Ltd announced the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd.

Femasys, Inc announces the achievement of regulatory approvals in Australia and New Zealand for its next-generation infertility solutions: FemaSeed® for first-line intratubal insemination treatment and FemVue® for diagnostic evaluation.

GRI Bio, Inc announced the completion of patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").

Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.2

Soleno Therapeutics, announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets, previously known as DCCR, have been selected for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025), which is being held July 12-15, 2025, in San Francisco, CA.

Adaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable residual disease (MRD) assessment in lymphoid malignancies into OncoEMR®, Flatiron's cloud-based Electronic Medical Record (EMR) platform.

BioXcel Therapeutics announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia.

Novocure announced that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer.

NanoViricides, Inc announces that it is forging ahead with advancing its lead candidate NV-387 into Phase II clinical drug development.

atai Life Sciences and Beckley Psytech Limited jointly announced positive topline results from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD).