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RSS FeedPosted by Michael Wonder on 10 Nov 2017
Heron Therapeutics announces U.S. FDA approval of Cinvanti (aprepitant) injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting
9 November 2017 - U.S. commercial launch of Cinvanti is planned for January 2018. ...
Posted by Michael Wonder on 10 Nov 2017
Seattle Genetics announces FDA approval of Adcetris (brentuximab vedotin) for primary cutaneous anaplastic large cell lymphoma and CD30 expressing mycosis fungoides
9 November 2017 - FDA approval based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator-sponsored studies ...
Posted 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8 November 2017 - New FDA draft guidance to streamline the submission and review process for shared system REMS.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
EMA gets ready for relocation decision
7 November 2017 - Close collaboration with new host country as of day one key for successful move. ...
Posted by Michael Wonder on 07 Nov 2017
Health Canada approves Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer
6 November 2017 - Approval granted based on promising tumour response rate and duration of response. ...
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
Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency
6 November 2017 - The application for marketing approval is based on the COMPASS study. ...
Posted by Michael Wonder on 06 Nov 2017
FDA approves Genentech’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer
6 November 2017 - Approval based on Phase III results that showed Alecensa extended the average time that people lived without ...
Posted by Michael Wonder on 06 Nov 2017
Health Canada approves Otsuka and Lundbeck's Abilify Maintena (aripiprazole once Monthly) as treatment for bipolar I disorder in adults
2 November 2017 - Otsuka Canada and Lundbeck Canada announce that Health Canada issued a Notice of Compliance for Abilify Maintena ...