FDA

HeartBeam, Inc. announced that the study enrolled 486 patients with data analysis underway and the results anticipated to be presented at a cardiology conference in 2027.

HeartBeam, Inc announced that the HEADSTART-ACS study, conducted at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia, has completed enrollment ahead of schedule.

Lexicon Pharmaceuticals, Inc today highlighted findings from two newly reported preclinical studies that provide additional insight into the biological effects of sotagliflozin, Lexicon's first-in-class dual SGLT1 and SGLT2 inhibitor.

Achieve Life Sciences, Inc. announced positive 52-week efficacy results from its long-term, open-label ORCA-OL clinical trial evaluating cytisinicline for cigarette smoking and e-cigarette cessation.

Sutro Biopharma, Inc. announced that the first patient has been dosed in its Phase 1 trial of STRO-006 in patients with a range of solid tumors.

ImmunityBio, Inc announced completion of the database lock for Cohort A of QUILT-2.005 (NCT02138734), its randomized, controlled, registrational trial evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve NMIBC.

Kyverna Therapeutics, announced the full one-year data set from KYSA-8, its registrational trial of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome (SPS).

INmune Bio Inc. announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB).

BioCryst Pharmaceuticals, Inc announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older.

Unicycive Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Invivyd, Inc. announced the presentation of preclinical data describing its novel, potential first- and best-in-class investigational monoclonal antibody candidate VMS063 at IDWeek 2026™ in Washington, D.C. Data demonstrated highly potent in vitro antiviral activity against contemporary measles fusion protein (MeV-F) variants, supporting its potential utility for both treatment and prevention (pre/post-exposure prophylaxis) of measles.

Jade Biosciences, Inc announced that three posters related to JADE101, a novel, ultra-high affinity and half-life extended investigational anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody in development for the treatment of immunoglobulin A nephropathy (IgAN), will be presented at the American Society of Nephrology (ASN) Kidney Week 2026, being held in Denver, Colorado from October 21-25, 2026.

- Immunic, Inc. announced that new clinical, biomarker, and preclinical data for its lead investigational asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), are being presented across four poster presentations at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting, taking place October 21-23, 2026, in Toronto.

Opus Genetics, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OPGx-RDH12, an investigational gene therapy for the treatment of RDH12-associated Leber congenital amaurosis (RDH12-LCA), a rare inherited retinal disease that causes progressive vision loss and blindness beginning in early childhood.

Merck Receives European Commission Approval For KEYTRUDA In Combination With Padcev For Adults With Resectable Muscle-Invasive Bladder Cancer

Personalis, Inc announced that two oral presentations and two poster presentations featuring its NeXT Personal ultrasensitive circulating tumor DNA (ctDNA) test will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23-27 in Madrid, Spain. Highlights include a late-breaking oral presentation of NeXT Personal data for the C-POST Phase 3 study in cutaneous squamous cell carcinoma, as well as a Rapid Oral presentation from B-STRONGER-1, a prospective, multicenter study evaluating NeXT Personal for detecting molecular residual disease in patients with early-stage triple-negative breast cancer receiving neoadjuvant therapy.

Summit Therapeutics Inc. announced a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in a registration-enabling Phase II/III study in biliary tract cancer (BTC).

Ascentage Pharma Group announced today that lisaftoclax (APG-2575), the Company’s novel Bcl-2 inhibitor, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), in combination with acalabrutinib, for the treatment of treatment-naïve adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Hibsago(bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg) levels ≤3000 IU/ml, as determined by an FDA-authorized test. GSK licensed bepirovirsen from Ionis and collaborated with them on its development.

NanoViricides, Inc announces that its broad-spectrum antiviral drug NV-387 has successfully demonstrated strong safety, tolerability, and toxicological parameters in an animal model study involving juvenile mouse pups.

AstraZeneca announced Full results from the positive Phase III CROSSING trial showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) demonstrated statistically significant and clinically meaningful improvements in the co-primary endpoints of histologic remission and the frequency and severity of dysphagia (difficulty swallowing) in adolescent and adult patients with symptomatic and uncontrolled eosinophilic esophagitis (EoE), despite continued treatment with background medications.

Neurocrine Biosciences, announced the initiation of its Phase 2 clinical study of investigational compound NBI-1117567 (NBI-'567) in adults with mild to moderate Alzheimer's disease.

Arcus Biosciences, Inc announced new data at an investor event in New York City from the ARC-20 platform study, which is evaluating casdatifan, an investigational next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC).

BioVie Inc. announced the presentation of results from the Phase 2 SUNRISE-PD clinical trial evaluating bezisterim in early Parkinson’s patients at the 151st Annual Meeting of the American Neurological Association (ANA), held October 17–20, 2026, in San Diego, California.

Revolution Medicines, Inc announced that it has begun treating patients in RASolve 308, a global Phase 3 clinical trial evaluating zoldonrasib, an investigational, RAS(ON) G12D-selective inhibitor, in combination with standard of care pembrolizumab plus chemotherapy as a first-line treatment in adult patients with metastatic RAS G12D non-squamous non-small cell lung cancer (NSCLC).

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd and Sanofi announced new positive data from the RELIEVE UCCD phase 2b long-term extension (LTE) study (clinical trial identifier: NCT05668013) in patients with moderately-to-severely active ulcerative colitis (UC) or Crohn’s disease (CD), which demonstrated that duvakitug maintained clinically meaningful efficacy improvements across multiple endpoints over 44 weeks.

IceCure Medical Ltd announced the enrollment of the first two patients at two U.S. clinical sites in its post-marketing study (the "ChoICE Study") evaluating ProSense® cryoablation for the local treatment of low-risk breast cancer.

Actinium Pharmaceuticals, Inc announced new preclinical results demonstrating the broad antitumor potential of ATNM-400 across non-small cell lung cancer (NSCLC), colorectal cancer and ovarian cancer models.

Neurogene Inc announced that it will present data from its NGN-401 gene therapy program for Rett syndrome at the European Society of Gene and Cell Therapy (ESGCT) 33rd Annual Congress, taking place October 27-30, 2026, in Hamburg, Germany.

Odyssey Therapeutics, Inc. announced results from the completed induction period of its Phase 2a clinical trial evaluating OD-001, an oral, selective RIPK2 scaffolding inhibitor, in patients with moderate-to-severe ulcerative colitis (UC).

Quoin Pharmaceuticals Ltd. announced the publication of a peer-reviewed manuscript titled "An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use Case Report" in Dermatology and Therapy.

Rapport Therapeutics, Inc. announced positive topline results from its Phase 2 trial of RAP-219 in adults with acute bipolar mania.

Alvotech announced that the U.S. Food and Drug Administration (FDA) has approved a new manufacturing process for SIMLANDI® (adalimumab-ryvk), Alvotech’s biosimilar to Humira® (adalimumab).

Oculis Holding AG announced that new biomarker data from the Phase 2 ACUITY trial of Privosegtor will be featured in a late-breaking session at the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto 2026), on October 21-23, 2026, in Toronto, Canada.