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RSS FeedPosted by Michael Wonder on 15 Nov 2017
Janet Woodcock wants you to know the FDA is not picking speed over safety in drug approvals
14 November 2017 - What is the biggest difference in working at the FDA under its new commissioner, Scott Gottlieb? ...
Posted by Michael Wonder on 15 Nov 2017
Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib
15 November 2017 - Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival. ...
Posted by Michael Wonder on 15 Nov 2017
Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma
14 November 2017 - FDA approval based on Phase III programme demonstrating up to 51% reduction in asthma exacerbations, significant improvement ...
Posted by Michael Wonder on 14 Nov 2017
Theratechnologies announces decision by the FDA to extend the ibalizumab review period to 3 April 2018
13 November 2017 - Theratechnologies announced that it was notified today by its partner, TaiMed Biologics that the U.S. FDA ...
Posted by Michael Wonder on 14 Nov 2017
EMD Serono receives FDA approval for new Gonal-f RFF Redi-ject pen
13 November 2017 - Redesigned pen injector developed based on insights of healthcare professionals and fertility patients. ...
Posted by Michael Wonder on 14 Nov 2017
The Supreme Court ruling in Sandoz v Amgen
13 November 2017 - A victory for follow-on biologics. ...
Posted by Michael Wonder on 14 Nov 2017
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
13 November 2017 - New tool for patients taking Abilify. ...
Posted by Michael Wonder on 13 Nov 2017
High costs of FDA approval for formerly unapproved marketed drugs
13 November 2017 - In May 2017, the US FDA announced a Drug Competition Action Plan, designed to address competition and ...
Posted by Michael Wonder on 13 Nov 2017
Theravance Biopharma and Mylan submit new drug application to FDA for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
13 November 2017 - Filing supported by positive results from two pivotal Phase 3 efficacy studies and one 12 month ...
Posted by Michael Wonder on 13 Nov 2017
Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia
13 November 2017 - Label expansion includes new data showing long-term Vraylar therapy delayed time to relapse compared to placebo over ...
Posted by Michael Wonder on 13 Nov 2017
Trump chooses Alex Azar for Health and Human Services Secretary
13 November 2017 - President Trump nominated a pharmaceutical executive to be the next secretary of the Health and Human ...
Posted by Michael Wonder on 13 Nov 2017
Sunovion announces FDA acceptance for review of new drug application for dasotraline for the treatment of ADHD
10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 13 Nov 2017
Fortress Biotech announces Cellvation's CEVA101 granted FDA regenerative medicine advanced therapy designation for the treatment of traumatic brain injury
8 November 2017 - CEVA101 is being developed in partnership with The University of Texas Health Science Center at Houston. ...
Posted by Michael Wonder on 10 Nov 2017
U.S. FDA expands approval of Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
10 November 2017 - Approval based on data from the largest prospective trial in paediatric chronic myeloid leukaemia in chronic phase. ...
Posted by Michael Wonder on 10 Nov 2017
FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in the treatment of ADPKD
9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program ...