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Searching News Database:  Rare Pediatric Disease 

 HSMN NewsFeed - 28 Jan 2026
REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs
Regenerative Medicine FDA
 HSMN NewsFeed - 25 Mar 2025
Hubble Therapeutics Closes Series A Financing to Develop Gene Therapy Cure for LCA16
Biopharmaceuticals Ophthalmology Venture Capital
 HSMN NewsFeed - 5 Mar 2025
Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Biopharmaceuticals Oncology Mergers & Acquisitions
 HSMN NewsFeed - 31 Dec 2024
Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 Nov 2024
PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Feb 2024
Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jan 2023
Aeglea BioTherapeutics Announces Update to Corporate Structure to Increase Operational Efficiency
Biopharmaceuticals Personnel
 HSMN NewsFeed - 30 Nov 2022
Aeglea BioTherapeutics Appoints Jeffrey M. Goldberg as Chief Executive Officer
Biopharmaceuticals Personnel
 HSMN NewsFeed - 15 Nov 2022
Jnana Therapeutics Raises $107 Million to Advance Lead PKU Program and Progress Therapeutics Pipeline Discovered by the RAPID Platform
Biopharmaceuticals Venture Capital
 HSMN NewsFeed - 24 Aug 2022
Aeglea BioTherapeutics Announces Leadership Transition and Corporate Restructuring
Biopharmaceuticals Personnel
 HSMN NewsFeed - 19 Nov 2021
BioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Aug 2021
European Commission Approves BioMarin's VOXZOGO(R) (vosoritide) for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 15 Jul 2021
Aeglea BioTherapeutics Appoints Jim Kastenmayer as General Counsel
Biopharmaceuticals Personnel
 HSMN NewsFeed - 25 Jun 2021
BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 18 Dec 2020
Polaryx Therapeutics Receives Both Rare Pediatric Disease and Orphan Drug Designations for the Treatment of Niemann Pick Disease Types A and B With PLX-300
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 15 Dec 2020
Lilly Announces Agreement to Acquire Prevail Therapeutics
Biopharmaceuticals Neurology Mergers & Acquisitions
 HSMN NewsFeed - 25 Nov 2020
Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Aug 2020
Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 28 Jul 2020
HemoShear Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for HST5040 to Treat Methylmalonic Acidemia and Propionic Acidemia
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Mar 2020
FDA Grants Rare Pediatric Disease Designation to Stealth BioTherapeutics for Elamipretide for the Treatment of Barth Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Jan 2020
Aruvant Receives FDA Rare Pediatric Disease Designation for ARU-1801 for the Treatment of Sickle Cell Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Dec 2019
3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo(TM) for Ear Reconstruction in Microtia Patients
Devices Regenerative Medicine FDA
 HSMN NewsFeed - 21 Mar 2019
Enzyvant's Investigational Farber Disease Enzyme Replacement Therapy, RVT-801, Receives FDA Fast Track and Rare Pediatric Disease Designations
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2018
FDA Approves Gamifant(R) (emapalumab), the First and Only Treatment for Primary Haemophagocytic Lymphohistiocytosis (HLH)
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Oct 2018
Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Sep 2018
ARMGO Pharma Receives FDA Orphan Drug Designation for ARM210/S48168 for the Treatment of Ryanodine Receptor Type 1 Related Myopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Aug 2018
Audentes Announces Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by the FDA to AT132 for the Treatment of X-Linked Myotubular Myopathy
Biopharmaceuticals Regenerative Medicine FDA
 HSMN NewsFeed - 5 Jun 2018
Audentes Announces Priority Medicines (PRIME) Designation Granted by the European Medicines Agency to AT132 for the treatment of X-Linked Myotubular Myopathy
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 26 Mar 2018
Bayer Announces Completion of Rolling Submission of New Drug Application in the U.S. for Larotrectinib for the Treatment of TRK Fusion Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Dec 2017
GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex(R) (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 26 Dec 2017
Mallinckrodt To Acquire Sucampo Pharmaceuticals For Approximately $1.2 Billion
Biopharmaceuticals Mergers & Acquisitions
 HSMN NewsFeed - 11 Dec 2017
Polaryx Therapeutics Receives Orphan Drug Designation From the US FDA for the Treatment of Neuronal Ceroid Lipofuscinoses With PLX-100
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 23 Aug 2017
Epygenix Therapeutics Receives US FDA Orphan Drug Designation for EPX-300 for the Treatment of Patients With Dravet Syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 18 Jul 2017
Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Jul 2017
Prometic Announces Positive Long Term Clinical Data on Ryplazym(TM) in Plasminogen Congenital Deficiency and Provides Regulatory Update
Biopharmaceuticals
 HSMN NewsFeed - 25 Apr 2017
Epygenix Therapeutics Receives Orphan Drug Designation From the U.S. FDA for EPX-100 and EPX-200 in the Treatment of Patients With Dravet Syndrome
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 16 Mar 2017
Biostage Promotes Saverio La Francesca, M.D. to President
Devices Regenerative Medicine Personnel
 HSMN NewsFeed - 1 Mar 2017
Sangamo Therapeutics Receives Orphan Drug Designation from the FDA for SB-913 Genome Editing Treatment for MPS II
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Mar 2016
Heart Metabolics Announces Multiple Senior Appointments To Management Team
Biopharmaceuticals Cardiology Personnel
 HSMN NewsFeed - 5 Feb 2016
Amarantus Requests Rare Pediatric Disease Designation from US FDA for MANF in the Treatment of Retinitis Pigmentosa
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 29 Dec 2015
Amarantus Requests Rare Pediatric Disease and Orphan Drug Designations from US FDA for Engineered Skin Substitute in the Treatment of Giant Congenital Melanocytic Nevi
Devices Regenerative Medicine Dermatology FDA
 HSMN NewsFeed - 18 Mar 2015
U.S. Food and Drug Administration Approves Cholbam for the Treatment of Rare Bile Acid Synthesis Disorders and Grants Rare Pediatric Disease Priority Review Voucher
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jul 2014
Akashi Therapeutics Receives Fast Track Designation for HT-100 from FDA for the Treatment of Duchenne Muscular Dystrophy
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jul 2014
Akashi Therapeutics Receives Collective Funding of $1.5 Million to Support HT-100 Clinical Development
Biopharmaceuticals Venture Capital
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