Blog
RSS FeedPosted by Michael Wonder on 07 Sep 2018
FDA approves Grifols new GamaSTAN (immunoglobulin [human]) to treat patients exposed to hepatitis A and measles
4 September 2018 - New formulation is manufactured using Grifols' sophisticated caprylate chromatography process according to the highest quality and safety ...
Posted by Michael Wonder on 07 Sep 2018
Fibrocell announces FDA fast track designation of FCX-013 for treatment of moderate to severe localised scleroderma
5 September 2018 - Fibrocell Science today announced that the U.S. FDA has granted fast track designation to FCX-013, the Company’s ...
Posted by Michael Wonder on 06 Sep 2018
ITF Pharma announces FDA approval of Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis
6 September 2018 - Tiglutik, the first and only easy-to-swallow thickened riluzole liquid for ALS, will be commercially available mid-October of ...
Posted by Michael Wonder on 04 Sep 2018
FDA on pace for record generic approvals in 2018
4 September 2018 - With two months of data outstanding, the US FDA is on pace to approve a record ...
Posted by Michael Wonder on 03 Sep 2018
Cablivi (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura
3 September 2018 - In addition, U.S. FDA to conduct priority review of caplacizumab with a target action date of ...
Posted by Michael Wonder on 01 Sep 2018
FDA issues a complete response letter for new drug application for dasatroline for the treatment of ADHD
31 August 2018 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 30 Aug 2018
FDA approves Merck’s Delstrigo (doravirine with lamivudine and tenofovir disoproxil fumarate), a once daily fixed-dose combination tablet as a complete regimen and Pifeltro (doravirine), an NNRTI, both for the treatment of HIV-1 in appropriate patients
30 August 2018 - Approvals based on findings from the pivotal Phase 3 DRIVE-AHEAD and DRIVE-FORWARD trials evaluating the efficacy and ...
Posted by Michael Wonder on 30 Aug 2018
Bayer receives US approval for modern haemophilia A treatment Jivi with a step-wise prophylaxis dosing regimen
30 August 2018 - Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and ...
Posted by Michael Wonder on 28 Aug 2018
Akcea and Ionis receive complete response letter for Waylivra from FDA
27 August 2018 - Akcea Therapeutics today announced that they received a complete response letter from the Division of Metabolism and ...
Posted by Michael Wonder on 27 Aug 2018
Tetraphase Pharmaceuticals announces FDA approval of Xerava (eravacycline) for complicated intra-abdominal infection
27 August 2018 - Xerava achieved high clinical cure rates in clinical trials in patients with cIAI. ...
Posted by Michael Wonder on 27 Aug 2018
AbbVie announces Imbruvica (ibrutinib) plus rituximab approval by U.S. FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia, a rare type of blood cancer
27 August 2018 - Milestone represents ninth FDA approval for Imbruvica in less than five years since its initial approval. ...
Posted by Michael Wonder on 26 Aug 2018
FDA approves Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
23 August 2018 - Biacodex is pleased to announce that on 20 August 2018, the FDA has approved Diacomit (stiripentol) for ...
Posted by Michael Wonder on 25 Aug 2018
Ortho Dermatologics receives FDA approval for Altreno (tretinoin 0.05%) lotion for acne
24 August 2018 - Demonstrated tolerability and efficacy of a tretinoin in first and only once daily lotion formulation. ...
Posted by Michael Wonder on 24 Aug 2018
Shire announces FDA approval of Takhyzro (lanadelumab-flyo), a first-of-its-kind mAb preventive treatment for hereditary angioedema
23 August 2018 - Takhyzro is a subcutaneous injection that took the majority of patients one minute or less to self-administer. ...
Posted by Michael Wonder on 24 Aug 2018
Kala Pharmaceuticals announces FDA approval of Inveltys for the treatment of post-operative inflammation and pain following ocular surgery
23 August 2018 - First twice daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular ...