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RSS FeedPosted by Michael Wonder on 09 Aug 2017
Valeant Pharmaceuticals receives complete response letter from the FDA for latanoprostene bunod ophthalmic solution, 0.024% NDA
7 August 2017 - Valeant Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 08 Aug 2017
FDA approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to four years
7 August 2017 - Approval offers women additional flexibility for pregnancy prevention. ...
Posted by Michael Wonder on 07 Aug 2017
Teva announces FDA approval of Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol
7 August 2017 - Maintenance treatment option designed to eliminate the need for hand-breath co-ordination during inhalation. ...
Posted by Michael Wonder on 03 Aug 2017
FDA approves Mavyret for Hepatitis C
3 August 2017 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus ...
Posted by Michael Wonder on 03 Aug 2017
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukaemia
3 August 2017 - The U.S. FDA today approved Vyxeos for the treatment of adults with two types of acute myeloid ...
Posted by Michael Wonder on 03 Aug 2017
U.S. FDA approves expanded labeling for Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C in patients co-infected with HIV
1 August 2017 - New data for first approved pan-genotypic once-daily single tablet regimen for chronic hepatitis C virus infection. ...
Posted by Michael Wonder on 02 Aug 2017
FDA approves treatment for chronic graft versus host disease
2 August 2017 - The U.S. FDA today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with ...
Posted by Michael Wonder on 02 Aug 2017
FDA approves Kalydeco (ivacaftor) for more than 600 people ages 2 and older with cystic fibrosis who have certain residual function mutations
1 August 2017 - Vertex Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) ...
Posted by Michael Wonder on 01 Aug 2017
FDA approves new targeted treatment for relapsed or refractory acute myeloid leukaemia
1 August 2017 - The U.S. FDA today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory ...
Posted by Michael Wonder on 01 Aug 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
1 August 2017 - Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% (95% CI: ...
Posted by Michael Wonder on 29 Jul 2017
Lundbeck and Takeda receive complete response letter from the FDA for Trintellix (vortioxetine) sNDA
23 June 2017 - Lundbeck and Takeda today announced that after providing additional analysis, the U.S. FDA has issued a ...
Posted by Michael Wonder on 29 Jul 2017
Abilify Maintena® (aripiprazole) for extended-release injectable suspension approved by the U.S. FDA for maintenance monotherapy treatment of bipolar I disorder
28 July 2017 - New indication for Abilify Maintena is based on studies evaluating efficacy and safety in adult patients with ...
Posted by Michael Wonder on 27 Jul 2017
Eagle Pharmaceuticals receives complete response letter from FDA on Ryanodex for exertional heat stroke application
26 July 2017 - Eagle Pharmaceuticals announced today that it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 27 Jul 2017
FDA approves Eisai's Fycompa (perampanel) for use as monotherapy for the treatment of partial-onset seizures
26 July 2017 - First anti-epileptic drug to apply FDA's regulatory pathway of extrapolation for monotherapy use; FDA proposed using this ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA expands approval of Yervoy (ipilimumab) to include paediatric patients 12 years and older with unresectable or metastatic melanoma
24 July 2017 - First Bristol-Myers Squibb immuno-oncology approval for adolescents 12 years and older reflects the company’s commitment to the ...