FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine. Current worldwide generic ketamine market is estimated at $750

PolarityBio thanks the clinical trial sites and, most importantly, the participants, for making this milestone in DFU biologic therapy development possible Final trial results anticipated in the first quarter of 2026 Dec. 02, 2025 -- PolarityBio©, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the successful completion of the COVER DFUS II trial, a Pivotal Phas

sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key secondary endpoints met with high statistical significance (p <0.0001) Favorable recurrence outcomes at one-year follow-up BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually1 Dec. 02, 2025 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofron

Dec. 01, 2025 -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel treatments for recurrent and metastatic cancer, today announced that it has submitted a request for a foreign filing license from Spain for two provisional patents detailing new methods to treat resistant cancer and fibrosis. The patents will be filed with IP Australia under Propanc Pty Ltd, the Company’s wholly owned operating subsidiary based in Melbourne, Austral

Dec. 01, 2025 -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX. TitleRhenium (186Re) obisbemeda (rhenium nanoliposome, 186RNL) for t

Dec. 01, 2025 -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Lotus Pharmaceutical Co., Ltd. (“Lotus”, TWSW Stock Code: 1795) today announced that Lotus has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the review and approval of VIZZTM, for the treatment of presbyopia in adults in South Korea. This represents the first submission for approval under the exclusive license and commercialization agreement signed in May 2025 for South Korea and certain coun

Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first three patients by the University of Bonn, Germany into its pivotal Phase 3 Serenta trial of eRapa in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colo

Dec. 01, 2025 -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing inflammation and immunology therapies targeting innate immune dysfunction, announces new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer’s disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), being held on December 1-4, 2025 in San Diego, CA. The new analyse

Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates overall response rate and safety profile consistent with the 1500mg QW dose Data inform and advance progress toward dose selection for ongoing pivotal FORTIFI-HN01 clinical trial of ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Company to host conference call and webcast on Saturday, December 6, 2025 at 9:00 a.m. ET Dec. 01, 2025 -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage

Nov. 25, 2025 -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric disorders, today announced that the Company will present the results of its Phase 2a trial of RAP-219 in focal onset seizures (FOS), along with new efficacy analysis, at the upcoming 2025 American Epilepsy Society (AES) Annual Meeting, taking p