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RSS FeedPosted by Michael Wonder on 07 May 2019
Savara announces Molgradex received fast track designation by FDA for treatment of auto-immune pulmonary alveolar proteinosis
6 May 2019 - Savara today announced that the U.S. FDA granted fast track designation for Molgradex, an inhaled formulation ...
Posted by Michael Wonder on 07 May 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
6 May 2019 - The U.S. FDA today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in patients ...
Posted by Michael Wonder on 06 May 2019
Pfizer gets U.S. approval for $225,000/year heart drug
6 May 2019 - The U.S. FDA on Monday approved Pfizer's oral drug, tafamidis, to treat a rare and fatal heart ...
Posted by Michael Wonder on 06 May 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin‑mediated amyloidosis
6 May 2019 - On May 3, the U.S. FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment ...
Posted by Michael Wonder on 06 May 2019
Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review
5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...
Posted by Michael Wonder on 04 May 2019
FDA approves Genentech's Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
3 May 2019 - Application approved under FDA’s real-time oncology review pilot program. ...
Posted by Michael Wonder on 04 May 2019
Qternmet XR approved in the US for the treatment of type 2 diabetes
3 May 2019 - The US FDA has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as ...
Posted by Michael Wonder on 03 May 2019
Acacia Pharma receives complete response letter from FDA for Barhemsys
3 May 2019 - Acacia Pharma announces that it has received a second complete response letter from the US FDA ...
Posted by Michael Wonder on 03 May 2019
Agios announces FDA approval of supplemental new drug application for Tibsovo as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukaemia not eligible for intensive chemotherapy
2 May 2019 - Approval based on 28 newly diagnosed patients from Phase 1 study of Tibsovo in advanced haematologic ...
Posted by Michael Wonder on 03 May 2019
Using instrumental variables to address bias from unobserved confounders
2 May 2019 - Randomised clinical trials are considered the most reliable source of evidence for the effects of medical interventions, ...
Posted by Michael Wonder on 02 May 2019
Pharmaceutical protections in U.S. trade deals — what do Americans get in return?
1 May 2019 - U.S. trade deals increasingly include terms affecting the approval process and availability of medicines. ...
Posted by Michael Wonder on 02 May 2019
Substandard control arms question the utility of some new cancer drugs
2 May 2019 - The rapid pace of new cancer drugs approved by the FDA, 16 in 2018 alone, is ...
Posted by Michael Wonder on 02 May 2019
The antibiotic industry is broken
2 May 2019 - Take inspiration from the entertainment industry. ...
Posted by Michael Wonder on 02 May 2019
FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices
2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...
Posted by Michael Wonder on 02 May 2019
FDA's efforts to advance the development of gene therapy
1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...