Blog
RSS FeedPosted by Michael Wonder on 06 Mar 2018
FDA authorises, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
6 March 2018 - Test only reports 3 out of more than 1,000 known BRCA mutations and negative result doesn’t rule ...
Posted by Michael Wonder on 03 Mar 2018
Otonomy announces FDA approval of Otiprio for acute otitis externa
2 March 2018 - Otonomy today announced that the U.S. FDA has approved Otiprio (ciprofloxacin 6% otic suspension) for the treatment ...
Posted by Michael Wonder on 01 Mar 2018
Sorrento Therapeutics subsidiary, Scilex, receives US FDA approval for non-opioid ZTlido (lignocaine topical system) 1.8% for PHN pain
28 February 2018 - ZTlido uses novel technology demonstrating 12 hour wear for efficient lignocaine delivery, even during exercise. ...
Posted by Michael Wonder on 27 Feb 2018
Lilly receives additional FDA approval for Verzenio (abemaciclib), as initial treatment for advanced breast cancer
26 February 2018 - New indication based on MONARCH 3 trial can help more women living with HR+, HER2- advanced breast ...
Posted by Michael Wonder on 24 Feb 2018
KemPharm announces FDA approval of Apadaz (benzhydrocodone and paracetamol) for the short-term management of acute pain
23 February 2018 - Apadaz is the first pro-drug of hydrocodone/paracetamol to be approved by FDA. ...
Posted by Michael Wonder on 21 Feb 2018
Mylan receives tentative approval for combination HIV treatment DTG/FTC/TAF under FDA's PEPFAR program
20 February 2018 - Mylan's DTG/FTC/TAF will be the first TAF-based fixed-dose combination to be offered to patients in developing ...
Posted by Michael Wonder on 19 Feb 2018
FDA approves Osmotica Pharmaceutical’s once-daily Osmolex ER (amantadine) extended-release tablets for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adults
19 February 2018 - Osmotica Pharmaceutical announced today that the U.S. FDA has approved Osmolex ER, an amantadine extended release tablet, ...
Posted by Michael Wonder on 17 Feb 2018
Apricus Biosciences receives complete response letter from FDA for Vitaros
16 February 2018 - Company evaluating deficiencies and potential path forward. ...
Posted by Michael Wonder on 16 Feb 2018
FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
16 February 2018 - The U.S. FDA today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell ...
Posted by Michael Wonder on 15 Feb 2018
AMAG Pharmaceuticals announces FDA approval of Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector to reduce the risk of preterm birth in certain at-risk women
14 February 2018 - Marks second FDA approval for AMAG this month ...
Posted by Michael Wonder on 14 Feb 2018
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
14 February 2018 - The U.S. FDA today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that ...
Posted by Michael Wonder on 13 Feb 2018
Icon Bioscience receives FDA approval for Dexycu, a potentially transformational drug therapy for treating inflammation associated with cataract surgery
12 February 2018 - Icon Bioscience today announced that the United States FDA has approved the company's new drug application for ...
Posted by Michael Wonder on 13 Feb 2018
Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
13 February 2018 - Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL. ...
Posted by Michael Wonder on 13 Feb 2018
FDA approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene
12 February 2018 - Symdeko to begin shipping to pharmacies this week. ...
Posted by Michael Wonder on 10 Feb 2018
Grifols HyperRAB (rabies immune globulin [human]) 300 IU/mL receives FDA approval to treat patients exposed to rabies virus infection
6 February 2018 - Reduced volume of medication offers potential for fewer injections for patients. ...