Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2019
Sandoz resubmits biosimilar pegfilgrastim application to US FDA
2 April 2019 - Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim. ...
Posted by Michael Wonder on 02 Apr 2019
Statement from FDA Commissioner on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
2 April 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...
Posted by Michael Wonder on 01 Apr 2019
Ziopharm Oncology announces FDA fast track designation for Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma
1 April 2019 - Ziopharm Oncology today announced that the U.S. FDA has granted fast track designation for its Controlled ...
Posted by Michael Wonder on 01 Apr 2019
Luye Pharma's Rykindo expected to be the first Chinese innovative drug to receive U.S. FDA approval
28 March 2019 - Luye Pharma Group has announced submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Apr 2019
Selumetinib granted US breakthrough therapy designation in neurofibromatosis type 1
1 April 2019 - Selumetinib is a MEK 1/2 inhibitor being co-developed by AstraZeneca and MSD. ...
Posted by Michael Wonder on 01 Apr 2019
Circassia announces FDA approval of Tudorza supplemental new drug application
29 March 2019 - Data showing reduction in COPD exacerbations and no increase in major cardiovascular events vs placebo added to ...
Posted by Michael Wonder on 01 Apr 2019
U.S. FDA acknowledges receipt of Intellipharmaceutics' resubmission of oxycodone ER new drug application, deems it a complete response, and designates 28 August 2019 as goal date for review
29 March 2019 - Intellipharmaceutics announced today that the U.S. FDA has acknowledged receipt of its resubmission of the Oxycodone ER ...
Posted by Michael Wonder on 30 Mar 2019
Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward
29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...
Posted by Michael Wonder on 30 Mar 2019
Spero Therapeutics receives FDA fast track designation for SPR994 for the treatment of complicated urinary tract infections and acute pyelonephritis
29 March 2019 - Spero Therapeutics today announced that the U.S. FDA granted fast track designation for SPR994, Spero’s lead product ...
Posted by Michael Wonder on 29 Mar 2019
FDA approves new oral treatment for multiple sclerosis
29 March 2019 - The U.S. FDA today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) ...
Posted by Michael Wonder on 29 Mar 2019
Janssen submits supplemental new drug application to U.S. FDA for Invokana (canagliflozin) for the treatment of chronic kidney disease in patients with type 2 diabetes mellitus
28 March 2019 - Submission is based on data from the landmark Phase 3 CREDENCE renal outcomes study, which stopped early ...
Posted by Michael Wonder on 29 Mar 2019
Amarin submits supplemental new drug application to U.S. FDA seeking new indication for Vascepa (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on landmark REDUCE-IT cardiovascular outcomes study
28 March 2019 - Amarin Corporation today announced that, as planned, it submitted a supplemental new drug application to the U.S. ...
Posted by Michael Wonder on 28 Mar 2019
Hospital pharmacists face dozens of drug shortages yearly
28 March 2019 - More than two-thirds of pharmacists in U.S. hospitals deal with at least 50 drug shortages every year, ...
Posted by Michael Wonder on 28 Mar 2019
Why J&J raced to put drug prices in some TV ads
28 March 2019 - One notion proposed by the Trump administration to blunt the rising cost of medicines is to ...
Posted by Michael Wonder on 28 Mar 2019
Drug makers continue to clamour for FDA approval of orphan drugs
28 March 2019 - Orphan drugs may serve small groups of patients, but they generate big numbers at the Food ...