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RSS FeedPosted by Michael Wonder on 24 Jun 2019
Correvio resubmits Brinavess (vernakalant) new drug application to U.S. FDA for the treatment of patients with recent onset atrial fibrillation
24 June 2019 - Correvio Pharma today announced it has resubmitted a new drug application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 20 Jun 2019
Pathway to US approval clarified after FDA issues complete response letter on use of Bronchitol for adult CF patients
20 June 2019 - Pharmaxis today announced its US licensee Chiesi has received a complete response letter from the US ...
Posted by Michael Wonder on 19 Jun 2019
Melinta Therapeutics announces U.S. FDA acceptance of supplemental new drug application for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia
19 June 2019 - Application seeks to expand label to include an indication and phase III data for the treatment of ...
Posted by Michael Wonder on 15 Jun 2019
Blueprint Medicines submits new drug application to U.S. FDA for avapritinib for the treatment of PDGFRA exon 18 mutant GIST and fourth-line GIST
14 June 2019 - Blueprint Medicines Corporation today announced it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 13 Jun 2019
FDA grants priority review to Genentech’s Rituxan (rituximab) in children with two rare blood vessel disorders
12 June 2019 - If approved, this would be the first paediatric indication for Rituxan. ...
Posted by Michael Wonder on 11 Jun 2019
Should the FDA disclose new filings for drugs, biologics and biosimilars?
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...
Posted by Michael Wonder on 06 Jun 2019
Xeris Pharmaceuticals receives notification of PDUFA date extension for Gvoke
6 June 2019 - Xeris Pharmaceuticals announced today that the U.S. FDA has extended the initial Prescription Drug User Fee ...
Posted by Michael Wonder on 06 Jun 2019
US FDA and EMA accept applications for ozanimod for the treatment of relapsing forms of multiple sclerosis
6 June 2019 - Celgene Corporation today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 06 Jun 2019
Alnylam completes rolling submission of new drug application to U.S. FDA for givosiran for the treatment of acute hepatic porphyria
5 June 2019 - First potential treatment demonstrating substantial reduction in the frequency of porphyria attacks. ...
Posted by Michael Wonder on 04 Jun 2019
Hiding in plain sight: the FDA’s approach to disclosing new drug applications is a disservice to public health
4 June 2019 - Remember in high school when a friend told you a secret and you guarded it assiduously, ...
Posted by Michael Wonder on 04 Jun 2019
Celgene Corporation and Acceleron Pharma announce U.S. FDA accepts luspatercept biologics license application in myelodysplastic syndromes and beta-thalassemia
4 June 2019 - U.S. FDA grants priority review for beta-thalassemia indication and sets target action date of 4 December ...
Posted by Michael Wonder on 04 Jun 2019
U.S. FDA accepts new drug application for triple combination tablet for adults with type 2 diabetes
4 June 2019 - The U.S. FDA has accepted the new drug application for the investigational fixed-dose combination tablet of empagliflozin, ...
Posted by Michael Wonder on 04 Jun 2019
Public disclosure of the filing of new drug and therapeutic biologics applications with the US Food and Drug Administration
3 June 2019 - Current regulations prohibit the US FDA from publicly disclosing the existence of pending new drug applications or ...
Posted by Michael Wonder on 03 Jun 2019
Galt Pharmaceuticals answers the call for better practices in pain management with a non-opioid therapeutic alternative
29 May 2019 - Officials with the FDA have given priority review designation to an opioid-free pain management treatment from ...
Posted by Michael Wonder on 31 May 2019
U.S. FDA grants priority review for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma
30 May 2019 - 26 September 2019 PDUFA date. ...