orphan drugs

AstraZeneca’s Combination Treatment for HCC Snags Orphan Drug Designation
AstraZeneca’s Combination Treatment for HCC Snags Orphan Drug Designation
BioSpace
AstraZeneca
Imfinzi
orphan drugs
FDA
hepatocellular carcinoma
Flag link:
FDA to Allow Online Submissions of Orphan Designation Requests
FDA to Allow Online Submissions of Orphan Designation Requests
RAPS.org
FDA
orphan drugs
Flag link:
‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity
‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity
RAPS.org
FDA
orphan drugs
orphan exclusivity
Neurelis
Valtoco
Flag link:
FDA: 2019 Continues Uptick in Orphan Drug Approvals
FDA: 2019 Continues Uptick in Orphan Drug Approvals
RAPS.org
FDA
drug approvals
orphan drugs
Flag link:
FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
RAPS.org
FDA
orphan drugs
Indivior
Sublocade
opioid use disorder
Flag link:
Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension
Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension
Pharmaceutical Business Review
Acceleron
orphan drugs
sotatercept
PAH
Flag link:
Who will be the biggest pharma players in orphan drugs?
Who will be the biggest pharma players in orphan drugs?
Pharmaforum
orphan drugs
Roche
M&A
AbbVie
JNJ
Flag link:
AstraZeneca’s Fasenra gets FDA ODD status for eosinophilic oesophagitis
AstraZeneca’s Fasenra gets FDA ODD status for eosinophilic oesophagitis
Pharmaceutical Business Review
AstraZeneca
Fasenra
orphan drugs
FDA
eosinophilic esophagitis
Flag link:
AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer
AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer
Pharmaceutical Business Review
AstraZeneca
Imfinzi
FDA
small cell lung cancer
orphan drugs
Flag link:
Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD
Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD
Pharmaceutical Business Review
Reata Pharmaceuticals
ADPKD
autosomal dominant polycystic kidney disease
Bardoxolone
orphan drugs
FDA
Flag link:
Orphan drugs market to soar to $224bn by 2024
Orphan drugs market to soar to $224bn by 2024
PM Live
orphan drugs
Zolgensma
LentiGlobin
Evaluate Pharma
Flag link:
Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!
Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!
FDA Law Blog
orphan drugs
FDA
Flag link:
Report: Evaluating the Cost-Effectiveness and Controversies of Orphan Drugs
Report: Evaluating the Cost-Effectiveness and Controversies of Orphan Drugs
BioSpace
orphan drugs
Orphan Drug Act
Flag link:
Clinical Costs for Orphan Drugs Lower Than Non-Orphan Drugs, Study Finds
Clinical Costs for Orphan Drugs Lower Than Non-Orphan Drugs, Study Finds
RAPS.org
orphan drugs
Rare Diseases
Flag link:
New Industry Report Finds Most Orphan Drugs Aren't Successful
New Industry Report Finds Most Orphan Drugs Aren't Successful
BioSpace
orphan drugs
Flag link:
FDA Faulted For Lapses In Orphan Drug Program
FDA Faulted For Lapses In Orphan Drug Program
NPR
FDA
orphan drugs
Rare Diseases
Flag link:
Astrazeneca's Fasenra Gets Orphan Drug Designation for Autoimmune Disease
Astrazeneca's Fasenra Gets Orphan Drug Designation for Autoimmune Disease
Yahoo/Zacks.com
AstraZeneca
Fasenra
orphan drugs
FDA
eosinophilic granulomatosis with polyangiitis
Flag link:
Failed as a Cancer Treatment - Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1
Failed as a Cancer Treatment - Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1
CP Wire
AstraZeneca
Merck
selumetinib
Array Biopharma
orphan drugs
NF1
neurofibromatosis
Flag link:
FDA Finalizes Guidance Closing Pediatric Study Loophole
FDA Finalizes Guidance Closing Pediatric Study Loophole
RAPS.org
FDA
orphan drugs
pediatrics
Flag link:
Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union
Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union
CP Wire
Inozyme Pharma
INZ-701
orphan drugs
Flag link:

Pages