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RSS FeedPosted 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
Enzyvant announces FDA acceptance of biologics license application and priority review status for RVT-802, a novel investigational tissue-based regenerative therapy for paediatric congenital athymia
5 June 2019 - RVT-802, a one-time therapy, leverages Enzyvant’s T cell generation platform designed to treat profound immunodeficiencies. ...
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 05 Jun 2019
Pharma groups combine to promote drug discovery with AI
5 June 2019 - Blockchain system allows companies to share data without revealing commercial secrets. ...
Posted by Michael Wonder on 05 Jun 2019
Sierra announces momelotinib granted FDA fast track designation
5 June 2019 - Fast Track designation highlights the potential for momelotinib to address the significant unmet needs of patients with ...
Posted by Michael Wonder on 05 Jun 2019
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
5 June 2019 - A team of researchers inside Pfizer made a startling find in 2015: the company's blockbuster rheumatoid ...
Posted by Michael Wonder on 04 Jun 2019
FDA approves Lilly’s migraine drug as first ever cluster headache treatment
4 June 2019 - The drug will be priced the same as for migraine on a per milligram basis, but the ...
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
FDA to make it easier for doctors to get unapproved cancer drugs for patients
3 June 2019 - Agency will work closely with physicians seeking treatments through its “expanded access” program. ...
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 04 Jun 2019
US FDA review for Scenesse extended by three months
3 June 2019 - The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision. ...
Posted by Michael Wonder on 04 Jun 2019
SpringWorks Therapeutics announces FDA fast track designation for PD-0325901 for the treatment of a severe form of neurofibromatosis type 1
3 June 2019 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for PD-0325901, an investigational, ...
Posted by Michael Wonder on 03 Jun 2019
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
3 June 2019 - The U.S. FDA today approved a new indication for the previously FDA approved drug, Zerbaxa (ceftolozane and ...