https://magazine.haei.org/gp-1-2025/kalvista-announces-orphan-drug-designation-and-nda-submission-for-sebetralstat-in-japan-for-hae/
KalVista announces orphan drug designation and nda submission for sebetralstat in Japan for HAE -...
Apr 10, 2025 - KalVista announces orphan drug designation and nda submission for sebetralstat in Japan for hereditary angioedema KalVista Pharmaceuticals announced that...
https://www.vanuatutechnologyupdate.com/article/854568470-aavantgarde-announces-fda-orphan-drug-designation-and-uk-cta-approval-for-aavb-039-for-the-treatment-of-stargardt-disease
AAVantgarde Announces FDA Orphan Drug Designation and UK CTA approval for AAVB-039 for the...
https://www.juvenatherapeutics.com/juvenas-juv-161-awarded-us-orphan-drug-designation-for-myotonic-dystrophy-type-1/
Juvena's JUV-161 awarded US orphan drug designation for myotonic dystrophy type 1 - Juvena...
https://in.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-s-Riliprubart-Secures-Orphan-Drug-Designation-in-Japan-50363503/
Sanofi's Riliprubart Secures Orphan Drug Designation in Japan | MarketScreener India
Jun 30, 2025 - Sanofi said Monday that Japan's Ministry of Health, Labour and Welfare granted orphan drug designation for riliprubart in chronic inflammatory demyelinating...
in japansanofiorphan
https://www.indianpharmapost.com/biotech/tezepelumab-granted-orphan-drug-designation-in-the-us-10421
Tezepelumab granted Orphan Drug Designation in the US
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic...
tezepelumabgrantedorphandrugdesignation
https://www.pharmafocusamerica.com/technotrends/lisata-therapeutics-achieves-orphan-drug-designation-from-us-fda
Lisata Therapeutics Achieves Orphan Drug Designation from U.S. FDA
Orphan Drug Designation is an FDA designation given to drugs or biologics intended to treat rare diseases or conditions affecting fewer than 200,000 people in...
u stherapeuticsorphandrugdesignation
https://gdc4gpat.com/blog-post/lupin-fda-grants-mexiletine-orphan-drug-designation-for-myotonic-disorders/
Lupin: FDA Grants Mexiletine Orphan Drug Designation For Myotonic Disorders | GPAT DISCUSSION CENTER
Jun 8, 2020 - India-based Lupin Limited announced Monday that the US Food and Drug Administration or FDA has granted Orphan Drug Designation or ODD to mexiletine...
https://medicaex.com/prnewswire/fda-grants-orphan-drug-designation-to-cevidoplenib-for-itp/
FDA Grants Orphan Drug Designation to Cevidoplenib for ITP - MedicaEx.com
Apr 1, 2024 - PANGYO, South Korea, March 21, 2024 /PRNewswire/ -- Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for...
fdagrantsorphandrugdesignation
https://www.sartartherapeutics.com/sartar-received-orphan-drug-designation-in-eu/
Sartar received Orphan Drug Designation in EU - Sartar Therapeutics
Aug 15, 2024 - We are pleased to announce that Sartar Therapeutics has been granted orphan drug designation in EU by the European Commission. See more on Community Register...
receivedorphandrugdesignationeu
https://microbiomepost.com/maat-pharma-announces-european-medicines-agency-granted-maat033-orphan-drug-designation-aiming-to-improve-overall-survival-in-patients-undergoing-hematopoietic-stem-cell-transplantation/
MaaT Pharma Announces European Medicines Agency Granted MaaT033 Orphan Drug Designation Aiming to...
Sep 7, 2023 - MaaT033 (capsule), which is being developed as an adjunctive and maintenance therapy to improve overall survival in allo-HSCT, has received orphan drug...
european medicines agency
https://www.prnewswire.co.uk/news-releases/berg-announces-fda-orphan-drug-designation-of-bpm-31510-for-the-treatment-of-patients-with-683435341.html
BERG Announces FDA Orphan-Drug Designation of BPM 31510 for the Treatment of Patients with...
/PRNewswire/ -- BERG, LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced that...
https://www.biospace.com/abm-therapeutics-abm-1310-granted-fast-track-designation-by-the-fda-following-orphan-drug-designation
ABM Therapeutics' ABM-1310 Granted Fast Track Designation by the FDA Following Orphan Drug...
Sep 26, 2023 - ABM Therapeutics is pleased to announce today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of...
by the fda
https://zytoprotec.com/de/news/orphan-drug-designation/
Orphan Drug Designation / zytoprotec.com
orphandrugdesignation
https://www.finnewsnetwork.com.au/archives/finance_news_network4512960.html
Immutep receives FDA orphan drug designation for efti in soft tissue sarcoma | Finance News Network
Apr 15, 2026 - 15 Apr 2026 - Designation for eftilagimod alfa follows promising Phase II trial data in rare cancer treatment.
https://www.businesswire.com/news/home/20250107878739/en/AliveGen-Receives-FDA-Orphan-Drug-Designation-for-ALG-801-for-Pulmonary-Arterial-Hypertension
AliveGen Receives FDA Orphan Drug Designation for ALG-801 for Pulmonary Arterial Hypertension
AliveGen USA Inc. (AliveGen), a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan...