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RSS FeedPosted by Michael Wonder on 14 Nov 2017
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
13 November 2017 - New tool for patients taking Abilify. ...
Posted by Michael Wonder on 13 Nov 2017
Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia
13 November 2017 - Label expansion includes new data showing long-term Vraylar therapy delayed time to relapse compared to placebo over ...
Posted by Michael Wonder on 10 Nov 2017
U.S. FDA expands approval of Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
10 November 2017 - Approval based on data from the largest prospective trial in paediatric chronic myeloid leukaemia in chronic phase. ...
Posted 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
Dynavax announces FDA approval of Heplisav-B for prevention of hepatitis B in adults
9 November 2017 - First and only two-dose vaccine in United States for prevention of hepatitis B in adults. ...
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 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 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 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
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
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 ...