Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 28 Mar 2019
FDA approves treatment for patients with a type of inflammatory arthritis
28 March 2019 - The U.S. FDA today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type ...
Posted by Michael Wonder on 28 Mar 2019
Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-05 for the treatment of major depressive disorder
27 March 2019 - Designation offers potential for expedited development and review. ...
Posted by Michael Wonder on 27 Mar 2019
Novartis makes new MS drug cheaper than its older option
27 March 2019 - Swiss drug maker’s Mayzent will cost less than older Gilenya. ...
Posted by Michael Wonder on 27 Mar 2019
FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism
27 March 2019 - The U.S. FDA today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain ...
Posted by Michael Wonder on 27 Mar 2019
Effectiveness in the absence of efficacy: cautionary tales from real world evidence
21 March 2019 - Real-world data are collected outside of traditional clinical trials and may include electronic health records, patient registries, ...
Posted by Michael Wonder on 27 Mar 2019
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma
26 March 2019 - Submission based on data from Phase III CASSIOPEIA study. ...
Posted by Michael Wonder on 26 Mar 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia with an IDH1 mutation in adult patients ineligible for intensive chemotherapy
26 March 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) in ...