orphan drugs

FDA to Allow Online Submissions of Orphan Designation Requests
RAPS.org
Fri, 01/17/20 - 11:46 pm
FDA
orphan drugs
‘Clinical Superiority’: FDA Finds Diazepam Nasal Spray Deserves Orphan Exclusivity
RAPS.org
Tue, 01/14/20 - 09:56 am
FDA
orphan drugs
orphan exclusivity
Neurelis
Valtoco
FDA: 2019 Continues Uptick in Orphan Drug Approvals
RAPS.org
Mon, 01/6/20 - 11:30 pm
FDA
drug approvals
orphan drugs
FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade
RAPS.org
Sun, 11/10/19 - 07:46 pm
FDA
orphan drugs
Indivior
Sublocade
opioid use disorder
Acceleron gets FDA orphan drug designation for sotatercept in pulmonary arterial hypertension
Pharmaceutical Business Review
Tue, 09/10/19 - 11:06 am
Acceleron
orphan drugs
sotatercept
PAH
Who will be the biggest pharma players in orphan drugs?
Pharmaforum
Sat, 09/7/19 - 06:25 pm
orphan drugs
Roche
M&A
AbbVie
JNJ
AstraZeneca’s Fasenra gets FDA ODD status for eosinophilic oesophagitis
Pharmaceutical Business Review
Thu, 08/29/19 - 10:28 am
AstraZeneca
Fasenra
orphan drugs
FDA
eosinophilic esophagitis
AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer
Pharmaceutical Business Review
Tue, 07/16/19 - 10:59 am
AstraZeneca
Imfinzi
FDA
small cell lung cancer
orphan drugs
Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD
Pharmaceutical Business Review
Thu, 06/6/19 - 12:09 pm
Reata Pharmaceuticals
ADPKD
autosomal dominant polycystic kidney disease
Bardoxolone
orphan drugs
FDA
Orphan drugs market to soar to $224bn by 2024
PM Live
Fri, 04/26/19 - 08:18 pm
orphan drugs
Zolgensma
LentiGlobin
Evaluate Pharma
Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!
FDA Law Blog
Wed, 03/27/19 - 11:08 pm
orphan drugs
FDA
Report: Evaluating the Cost-Effectiveness and Controversies of Orphan Drugs
BioSpace
Mon, 01/14/19 - 11:07 am
orphan drugs
Orphan Drug Act
Clinical Costs for Orphan Drugs Lower Than Non-Orphan Drugs, Study Finds
RAPS.org
Sat, 01/12/19 - 11:33 am
orphan drugs
Rare Diseases
New Industry Report Finds Most Orphan Drugs Aren't Successful
BioSpace
Mon, 12/17/18 - 08:22 pm
orphan drugs
FDA Faulted For Lapses In Orphan Drug Program
NPR
Sat, 12/1/18 - 11:53 am
FDA
orphan drugs
Rare Diseases
Astrazeneca's Fasenra Gets Orphan Drug Designation for Autoimmune Disease
Yahoo/Zacks.com
Tue, 11/27/18 - 12:09 pm
AstraZeneca
Fasenra
orphan drugs
FDA
eosinophilic granulomatosis with polyangiitis
Failed as a Cancer Treatment - Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1
CP Wire
Fri, 08/3/18 - 09:25 am
AstraZeneca
Merck
selumetinib
Array Biopharma
orphan drugs
NF1
neurofibromatosis
FDA Finalizes Guidance Closing Pediatric Study Loophole
RAPS.org
Fri, 07/27/18 - 10:35 am
FDA
orphan drugs
pediatrics
Inozyme Pharma Receives Orphan Drug Designation for INZ-701 in the United States and European Union
CP Wire
Tue, 07/17/18 - 09:59 am
Inozyme Pharma
INZ-701
orphan drugs
Seattle Genetics Announces Results of Two Ph II Trials of Tucatinib in HER2- Positive Metastatic Breast Cancer
CP Wire
Wed, 07/11/18 - 10:12 am
Seattle Genetics
tucatinib
orphan drugs
clinical trials
HER2-positive metastatic breast cancer
breast cancer

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