Blog
RSS FeedPosted by Michael Wonder on 26 Aug 2018
Krystal Biotechs’ KB105 receives rare paediatric disease designation from the FDA to treat patients with TGM-1-deficient autosomal recessive congenital ichthyosis
23 August 2018 - KB105 is Krystal’s second "off-the-shelf" topical gene therapy candidate to receive rare paediatric disease designation for treating ...
Posted by Michael Wonder on 25 Aug 2018
FDA says sponsors should limit placebo controlled trials in cancer
23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...
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 ...
Posted by Michael Wonder on 24 Aug 2018
Mallinckrodt and NPXe announce FDA fast track designation for Phase 3 trial of inhaled Xenon gas therapy
23 August 2018 - Drug to be studied for improved functional outcomes and survival rates for patients resuscitated after a cardiac ...
Posted by Michael Wonder on 23 Aug 2018
Case-control studies: using “real world” evidence to assess association
23 August 2018 - Associations between patient characteristics or treatments received and clinical outcomes are often first described using observational data, ...
Posted by Michael Wonder on 23 Aug 2018
FDA's new generic EpiPen approval exemplifies progress on drug price reform
23 August 2018 - Last week, FDA Commissioner Scott Gottlieb announced the approval of the first generic version of EpiPen, an ...
Posted by Michael Wonder on 23 Aug 2018
FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need
23 August 2018 - Today, the U.S. FDA announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis ...
Posted by Michael Wonder on 23 Aug 2018
U.S. FDA accepts for priority review BMS’ application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with relapsed or refractory multiple myeloma
23 August 2018 - Application based on results from Phase 2 ELOQUENT-3 study. ...
Posted by Michael Wonder on 23 Aug 2018
Novimmune submits marketing authorisation application in Europe for its lead drug emapalumab
22 August 2018 - Novimmune today announced that it has successfully submitted a marketing authorisation application to the EMA seeking marketing ...
Posted by Michael Wonder on 23 Aug 2018
Y-mAbs receives breakthrough therapy designation for naxitamab for the treatment of high risk neuroblastoma
21 August 2018 - Y-mAbs Therapeutics today announced that the company has received a breakthrough therapy designation for naxitamab, in combination ...
Posted by Michael Wonder on 22 Aug 2018
FDA approves first drug for neurotrophic keratitis, a rare eye disease
22 August 2018 - The U.S. FDA today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a ...
Posted by Michael Wonder on 22 Aug 2018
Mallinckrodt confirms receipt of stannsoporfin complete response letter
22 August 2018 - Mallinckrodt confirmed today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 22 Aug 2018
Statement by FDA Commissioner on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...