Blog
RSS FeedPosted by Michael Wonder on 09 Nov 2017
Merck receives FDA approval of Prevymis (letermovir) for prevention of cytomegalovirus infection and disease in adult allogeneic stem cell transplant patients
8 November 2017 - Cytomegalovirus prophylaxis with Prevymis associated with lower all-cause mortality through week 24 and week 48 post-transplant. ...
Posted by Michael Wonder on 09 Nov 2017
FDA is making it easier to meet required extra safety measures for certain FDA approved drugs
8 November 2017 - For some FDA approved drugs specific safety steps must be taken before the patient can receive the ...
Posted by Michael Wonder on 08 Nov 2017
Paediatric exclusivity and regulatory authority
8 November 2017 - In May 2017, the US FDA denied a 6-month extension of market exclusivity for Sensipar (cinacalcet), ...
Posted by Michael Wonder on 08 Nov 2017
Statement from FDA Commissioner Scott Gottlieb on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
8 November 2017 - New FDA draft guidance to streamline the submission and review process for shared system REMS. ...
Posted by Michael Wonder on 08 Nov 2017
Collegium receives FDA approval for sNDA for Xtampza ER
7 November 2017 - Comparative OxyContin data and oral human abuse deterrent claim added to label. ...
Posted by Michael Wonder on 08 Nov 2017
U.S. FDA approves Auryxia (ferric citrate) tablets as a treatment for people with iron deficiency anaemia and chronic kidney disease, not on dialysis
7 November 2017 - Auryxia is the only oral treatment option available today developed and approved specifically for adults living with ...
Posted by Michael Wonder on 08 Nov 2017
GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease
7 November 2017 - GlaxoSmithKline today announced the submission of a supplemental biologics license application to the United States FDA, ...
Posted by Michael Wonder on 07 Nov 2017
UCB’s Vimpat (lacosamide) now approved by FDA to treat partial-onset seizures in paediatric epilepsy patients
6 November 2017 - Approval builds on existing adult monotherapy and adjunctive therapy indications, broadening clinical application for Vimpat tablets and ...
Posted by Michael Wonder on 07 Nov 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
6 November 2017 - At a time when people are more aware of and engaged in their health care than ...
Posted by Michael Wonder on 07 Nov 2017
FDA clears common blood cell count test that offers faster results for patients and providers
6 November 2017 - The U.S. FDA today cleared a complete blood cell count test that, based on its categorisation, ...
Posted by Michael Wonder on 06 Nov 2017
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
6 November 2017 - FDA expands approval of Zelboraf (vemurafenib) to treat certain adult patients with Erdheim-Chester Disease, a rare cancer ...
Posted by Michael Wonder on 05 Nov 2017
FDA widens scope of Navigator – information tool for expanded access
2 November 2017 - FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, ...
Posted by Michael Wonder on 05 Nov 2017
Trevena announces submission of new drug application to U.S. FDA for Olinvo (oliceridine injection)
2 November 2017 - Filing supported by positive Phase 3 APOLLO and ATHENA studies. ...
Posted by Michael Wonder on 05 Nov 2017
Progenics Pharmaceuticals completes submission of NDA for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
2 November 2017 - Progenics Pharmaceuticals announced today that it has completed the rolling submission of its new drug application ...
Posted by Michael Wonder on 05 Nov 2017
Bausch & Lomb and Nicox announce FDA approval of Vyzulta (latanoprostene bunod ophthalmic solution), 0.024%
2 November 2017 - Valeant Pharmaceuticals' wholly owned subsidiary, Bausch & Lomb and Nicox today announced that the U.S. FDA has ...