Latest Headlines

31. FDA Accepts BioMarin's Supplemental New Drug Application To Expand Use Of VOXZOGO® (vosoritide) For Injection To Treat Children With Achondroplasia Under The Age Of 5 3/7/2023

    BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand treatment in the United States to include children with achondroplasia under the age of 5. Achondroplasia is the most common form of disproportionate short stature.

32. Amneal Announces U.S. FDA Filing Acceptance Of Abbreviated New Drug Application For Naloxone Hydrochloride Nasal Spray, USP, 4mg 3/2/2023

    Amneal Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan and is used in the treatment of a known or suspected opioid overdose emergency.

33. Janssen Submits New Drug Application To The U.S. Food And Drug Administration Seeking Approval Of Niraparib And Abiraterone Acetate Dual-Action Tablet, Plus Prednisone 3/1/2023

    The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).

34. Toragen, Inc. Announces FDA Acceptance Of IND Application For TGN-S11 For The Treatment Of HPV-Induced Cancers 2/28/2023

    Toragen, Inc., a San Diego-based biotechnology company focused on developing, repurposing and commercializing uniquely selective drugs targeting cancers caused by the human papillomavirus (“HPV”), announced today that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug (IND) application for the company’s lead product candidate, TGN-S11, for the treatment of HPV-induced cancers.

35. AION Labs Launches AI Startup For De Novo Antibody Design 2/28/2023

    AION Labs, the first-of-its-kind innovation lab spearheading the adoption of AI technologies and computational science to solve therapeutic challenges, announced today the formation of DenovAI, the lab's second startup approved by the Israel Innovation Authority.

36. Olink Establishes Agreement With Regeneron Genetics Center To Scale Their Proteomics Efforts, Potentially Enabling A New Era Of Drug Discovery 2/28/2023

    Olink Holding AB (publ) (Nasdaq: OLK) today announced an agreement with Regeneron Genetics Center® (RGC) focused on the use and development of Olink High-Plex offerings as a proteomics platform of choice, with a goal of generating proteomic data at scale to augment RGC’s vast genomics information store.

37. Lantern Pharma And TTC Oncology Establish AI Collaboration To Expand The Clinical Development Of Drug Candidate TTC-352 2/27/2023

    Lantern Pharma Inc. a clinical stage biopharmaceutical company using its proprietary RADRreg artificial intelligence ("AI") and machine learning (“ML”) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that it has entered into a research and development collaboration with TTC Oncology.

38. SeaStar Medical’s Selective Cytopheretic Device To Be Featured At The 5^th Chronic Kidney Disease Drug Development Summit 2/24/2023

    SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that Kevin Chung, M.D., Chief Medical Officer, will discuss the Company’s Selective Cytopheretic Device (SCD) in a presentation at the 5th Chronic Kidney Disease Drug Development Summit (CKD5) in Boston on March 7, 2023 at 10 a.m. Eastern Time.

39. PerkinElmer Launches EnVison Nexus Multimode Plate Reader To Drive Improved Research And Discovery Workflows 2/24/2023

    PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the EnVision Nexus system, its fastest and most sensitive multimode plate reader to date, designed for demanding high-throughput screening (HTS) applications and to accelerate drug discovery efforts.

40. Timber Pharmaceuticals Receives European Orphan Drug Designation For TMB-001 In X-Linked Recessive Ichthyosis 2/24/2023

    Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the European Commission (EC) granted orphan drug designation for TMB-001 for the treatment of X-linked recessive ichthyosis (XLRI) on February 15, 2023.