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RSS FeedPosted by Michael Wonder on 18 May 2018
F.D.A. approves first drug designed to prevent migraines
18 May 2018 - The first medicine designed to prevent migraines was approved by the FDA on Thursday, ushering in ...
Posted by Michael Wonder on 17 May 2018
FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention
17 May 2018 - Aimovig is the first and only FDA approved treatment to block the calcitonin gene-related peptide receptor, which ...
Posted by Michael Wonder on 17 May 2018
Statement from FDA Commissioner on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
17 May 2018 - No patients should be priced out of medicines they need to support their health. ...
Posted by Michael Wonder on 17 May 2018
Myonexus Therapeutics receives FDA rare paediatric drug designation for pioneering treatment of limb girdle muscular dystrophy Type 2E
16 May 2018 - Rare paediatric disease designation for MYO-101 program reflects compelling data and enables priority eeview voucher eligibility. ...
Posted by Michael Wonder on 17 May 2018
Castle Creek Pharmaceuticals receives FDA rare paediatric disease designation for diacerein 1% ointment for epidermolysis bullosa
16 May 2018 - Castle Creek Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation for diacerein ...
Posted by Michael Wonder on 17 May 2018
Addressing generic drug market failures - the case for establishing a non-profit manufacturer
17 May 2018 - Robust competition usually keeps the price of generic drugs well below that of brand-name drugs. When ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 17 May 2018
U.S. FDA accepts and acknowledges Coherus BioSciences biologics license application of CHS-1701 (pegfilgrastim biosimilar candidate) for review
14 May 2018 - Coherus BioSciences today announced the U.S. FDA has accepted and acknowledged for review the re-submission of the ...
Posted by Michael Wonder on 17 May 2018
Evolus announces progress with DWP-450 regulatory submissions
16 May 2018 - Evolus receives FDA complete response letter with comments isolated to CMC items. ...
Posted by Michael Wonder on 17 May 2018
FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
16 May 2018 - Encouraging more widespread innovation and development of safe and effective treatments for opioid use disorder remains top ...
Posted by Michael Wonder on 16 May 2018
FDA explores requiring drug price disclosures in commercials
15 May 2018 - Drug companies on Tuesday claimed the Trump administration may not have the legal authority to make ...
Posted by Michael Wonder on 16 May 2018
Evolving landscape of US FDA drug approval in the era of precision oncology: finding the right balance between access and safety
15 May 2018 - Since 1992, the US FDA has implemented several programs for streamlined review and approval of agents that ...
Posted by Michael Wonder on 16 May 2018
U.S. FDA approves expanded indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for reducing the risk of acquiring HIV-1 in adolescents
15 May 2018 - First agent indicated for uninfected adolescents at risk of acquiring HIV. ...
Posted by Michael Wonder on 15 May 2018
Aerie Pharmaceuticals submits new drug application to U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
15 May 2018 - Submitted as a 505(b)(2) with an expected ten month FDA review. ...
Posted by Michael Wonder on 15 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia
15 May 2017 - The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin ...