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RSS FeedPosted 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 ...
Posted by Michael Wonder on 15 May 2018
FDA to name companies accused of hindering generic drug development
14 May 2018 - On Thursday, the FDA plans to start publishing the names of pharmaceutical companies that have been ...
Posted by Michael Wonder on 15 May 2018
FDA approves subcutaneous formulation of Actemra for use in active polyarticular juvenile idiopathic arthritis, a rare form of juvenile arthritis
14 May 2018 - Genentech announced today that the U.S. FDA has approved the subcutaneous formulation of Actemra (tocilizumab) for the ...
Posted by Michael Wonder on 15 May 2018
UCB announces Briviact (brivaracetam) now approved by FDA to treat partial-onset (focal) seizures in paediatric epilepsy patients
14 May 2018 - Indication comes less than 2 years after the launch of Briviact in the U.S., building on existing ...
Posted by Michael Wonder on 15 May 2018
FDA grants fast track designation for Yamo Pharmaceutical’s L1-79 in autism spectrum disorder
14 May 2018 - Yamo Pharmaceuticals announced today that the US FDA has granted fast track designation for its investigational ...
Posted by Michael Wonder on 13 May 2018
Perrigo expects complete response letter on generic version of ProAir
11 May 2018 - Perrigo today announced that it expects to receive a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 12 May 2018
Statement from FDA Commissioner on the Trump Administration’s plan to lower drug prices
11 May 2018 - Today is an important day in the Administration’s collaborative effort to address the rising cost of ...