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RSS FeedPosted by Michael Wonder on 26 Jun 2018
FDA accepts supplemental biologics license application for Merck’s Keytruda (pembrolizumab) as adjuvant therapy in advanced melanoma
25 June 2018 - Application based on recurrence-free survival data from pivotal Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 26 Jun 2018
Stemline Therapeutics announces completion of rolling BLA submission for Elzonris (tagraxofusp; SL-401) for the treatment of BPDCN
25 June 2018 - Stemline Therapeutics announced today that it has completed submission of a rolling biologics license application to the ...
Posted by Michael Wonder on 26 Jun 2018
Historic new drug application for the use of Scenesse in rare metabolic disorder EPP
25 June 2018 - Priority review requested to FDA. ...
Posted by Michael Wonder on 25 Jun 2018
As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack
25 June 2018 - The pharmaceutical industry’s massive lobbying operation has a well-earned reputation for maintaining a united front on ...
Posted by Michael Wonder on 25 Jun 2018
Imbruvica (ibrutinib) supplemental new drug application accepted for review by U.S. FDA with potential to broaden treatment use as a combination treatment option with rituximab in Waldenström's macroglobulinemia, a rare form of blood cancer
25 June 2018 - The filing is based on data from the Phase 3 iNNOVATE study, which suggest that IMBRUVICA plus ...
Posted by Michael Wonder on 25 Jun 2018
Statement by FDA Commissioner on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
25 June 2018 - Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana ...
Posted by Michael Wonder on 25 Jun 2018
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
25 June 2018 - The U.S. FDA today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated ...
Posted by Michael Wonder on 23 Jun 2018
Nocdurna (desmopressin acetate) now approved by U.S. FDA as first sublingual tablet to treat nocturia due to nocturnal polyuria
21 June 2018 - Nocdurna sublingual tablets dissolve rapidly and have specific dosing designed for men and women to deliver a ...
Posted by Michael Wonder on 23 Jun 2018
Voyager Therapeutics announces FDA regenerative medicine advanced therapy designation granted for VY-AADC for the treatment of Parkinson’s Disease
21 June 2018 - Voyager Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for Voyager’s VY-AADC ...
Posted by Michael Wonder on 23 Jun 2018
HTX-011 for post-operative pain management receives breakthrough therapy designation from FDA
21 June 2018 - Heron Therapeutics today announced that HTX-011 for post-operative pain management has received breakthrough therapy designation from the ...
Posted by Michael Wonder on 22 Jun 2018
FDA announces program to enhance early communications with biological product developers
22 June 2018 - The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created ...
Posted by Michael Wonder on 22 Jun 2018
FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1
20 June 2018 - The FDA is restricting the use of Keytruda and Tecentriq for patients with locally advanced or ...
Posted by Michael Wonder on 21 Jun 2018
White House proposes a narrowing of FDA’s mission — and a new name
21 June 2018 - The Trump administration has proposed a fundamental change to the mission of the FDA, one that ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 21 Jun 2018
U.S. FDA accepts application for Opdivo plus low-dose Yervoy for treatment of first-line non-small cell lung cancer in patients with tumour mutational burden ≥10 mut/Mb
21 June 2018 - First-ever application for an I-O/I-O combination in lung cancer to be accepted. ...