Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2017
Teva Announces FDA approval of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease
3 April 2017 - Approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a ...
Posted by Michael Wonder on 03 Apr 2017
Novartis drug combination of Tafinlar & Mekinist receives EU approval for BRAF V600 positive advanced non-small-cell lung cancer
3 April 2017 - Approval based on data showing more than 60% overall response rate in both previously treated and untreated ...
Posted by Michael Wonder on 02 Apr 2017
Ibrance (palbociclib) receives FDA regular approval and expanded indication for first-line HR+, HER2- metastatic breast cancer
31 March 2017 - Pfizer today announced that the U.S. FDA has approved a supplemental new drug application for its first-in-class ...
Posted by Michael Wonder on 31 Mar 2017
FDA approves expanded indication for Qudexy XR (topiramate) extended release capsules to include prophylaxis of migraine headache in adults and adolescents
30 March 2017 - Molecule most prescribed by neurologists for migraine prophylaxis now available in a unique 24 hour formulation. ...
Posted by Michael Wonder on 30 Mar 2017
U.S. FDA approves addition of moderate to severe fingernail psoriasis data to AbbVie's Humira (adalimumab) prescribing information
30 March 2017 - Phase 3 data demonstrate improvement in moderate to severe fingernail psoriasis. ...
Posted by Michael Wonder on 29 Mar 2017
FDA approves Roche’s Ocrevus (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis
29 March 2017 - First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis – one of the ...
Posted by Michael Wonder on 29 Mar 2017
New fast-acting mealtime insulin, Fiasp, now approved and available in Canada for the treatment of diabetes
27 March 2017 - Faster absorption of insulin key for Canadians living with diabetes. ...
Posted by Michael Wonder on 29 Mar 2017
Drop in US drug approvals but no similar trend in the EU
28 March 2017 - NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the ...
Posted by Michael Wonder on 28 Mar 2017
Tesaro won’t reveal price of ovarian cancer drug. But it’ll likely be near $14,000 a month.
28 March 2017 - Zejula’s main rivals cost around $13,700 and $12,600 a month, but Tesaro might be able to justify ...
Posted by Michael Wonder on 28 Mar 2017
Severe eczema drug is approved by FDA; price tag is $37,000 a year
28 March 2017 - The FDA on Tuesday approved a drug to treat people with a serious form of eczema, ...
Posted by Michael Wonder on 28 Mar 2017
FDA approves new eczema drug Dupixent
28 March 2017 - The U.S. FDA today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent ...
Posted by Michael Wonder on 28 Mar 2017
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for the treatment of moderate to severe active rheumatoid arthritis
27 March 2017 - Approval provides people living with rheumatoid arthritis in the European Union with a new oral treatment option. ...
Posted by Michael Wonder on 28 Mar 2017
FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers
27 March 2017 - The U.S. FDA today approved Zejula (niraparib) for the maintenance treatment of adult patients with recurrent ...
Posted by Michael Wonder on 25 Mar 2017
European Medicines Agency’s CHMP recommends approval of Merck’s Keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma
24 March 2017 - Recommendation Is for adult patients who have failed autologous stem cell transplant and brentuximab vedotin or ...
Posted by Michael Wonder on 25 Mar 2017
FDA approves Symproic (naldemedine) once daily tablets C-II for the treatment of opioid-induced constipation in adults with chronic non-cancer pain
23 March 2017 - Shionogi and Purdue Pharma announced today that the U.S. FDA approved Symproic (naldemedine) 0.2 mg tablets ...