BioSpace News Archive

Trial did not achieve statistically significant improvement in heartburn severity (primary endpoint) – – Ironwood plans to implement organizational restructuring, resulting in expected headcount reduction of approximately 100 full-time employees, or nearly 35% of current workforce – – Expects total cost savings of greater than $95 million, excluding anticipated one-time costs – – Conference call to be held today at 8:30 a.m. ET –

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases, today announced it will participate in a Virtual Fireside Chat during the Chardan Genetic Medicines Conference on October 6th at 9 a.m.

BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Origin Biosciences today announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for fosdenopterin (previously BBP-870/ORGN001), a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, announced that its research team has discovered that a molecule within its portfolio of antimetabolites has displayed significant in vitro antiviral activity against SARS-CoV-2.

Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced that United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for a Phase 2 clinical trial studying lyo lucinactant

Achieving ISO-13485:2016 MDSAP Certification Affirms the Company’s Quality Management Systems Meet FDA, Health Canada and CE Mark Requirements HAYWARD, Calif.--( BUSINESS WIRE )-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced the receipt of Medical Device Single Audit Program certification. The Medical Device Single Audit Program (MDSAP) allows

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Infinity is currently enrolling patients in MAR

The Chicago Fire Department (CFD) will be joining forces with the American Cancer Society in Illinois (ACS-IL) to launch Breast Cancer Awareness Month. CFD — who currently has the

Medimetriks Pharmaceuticals, Inc. today announced that Otsuka Pharmaceuticals Co. Ltd., submitted an application for approval of MM36 (difamilast) to the Japanese regulatory authorities. Positive MM36 results in two Phase 3 Japanese clinical trials in adult and pediatric patients with mild to moderate atopic dermatitis (AD) we

OrthoSelect, a leading orthodontics software company and digital orthodontics lab, announces an exclusive partnership to manufacture and distribute the Owen Tripod Splint for treatment of bruxism and temporomandibular disorders.