Blog
RSS FeedPosted by Michael Wonder on 07 Jun 2018
Partner Therapeutics announces US FDA approval of Leukine (sargramostim) for the treatment of acute radiation syndrome
6 June 2018 - Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and paediatric ...
Posted by Michael Wonder on 06 Jun 2018
Clinical trial participants’ views of the risks and benefits of data sharing
7 June 2018 - Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants ...
Posted by Michael Wonder on 06 Jun 2018
FDA’s new efforts to advance biotechnology innovation
6 June 2018 - Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human ...
Posted by Michael Wonder on 05 Jun 2018
FDA proposes process modernisation to support new drug development
4 June 2018 - The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilise cutting-edge ...
Posted by Michael Wonder on 05 Jun 2018
Embracing competition to empower biosimilars
5 June 2018 - In 2017, there were 46 new novel drug innovations, including new treatments for cancers, Parkinson’s disease, ...
Posted by Michael Wonder on 05 Jun 2018
Postmarket studies required by the US FDA for new drugs and biologics approved between 2009 and 2012: cross-sectional analysis
24 May 2018 - Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at ...
Posted by Michael Wonder on 05 Jun 2018
FDA grants priority review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors
5 June 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 05 Jun 2018
FDA expands Lilly's Alimta (pemetrexed) label to include combination with Keytruda (pembrolizumab) and carboplatin as first-line treatment for metastatic non-squamous non-small cell lung cancer, irrespective of PD-L1 expression
5 June 2018 - New approval based on KEYNOTE-021, cohort G1, results. ...
Posted by Michael Wonder on 05 Jun 2018
Evoke announces FDA submission of new drug application for Gimoti
4 June 2018 - Evoke Pharma today announced the submission of its 505(b)(2) new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...
Posted by Michael Wonder on 04 Jun 2018
Statement from FDA Commissioner on proposed modernisation of FDA’s drug review office
4 June 2018 - Scientific and medical advances are giving the FDA more opportunities to more fully address diseases and ...
Posted by Michael Wonder on 04 Jun 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
4 June 2018 - The U.S. FDA today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the ...
Posted by Michael Wonder on 04 Jun 2018
Palatin Technologies announces FDA acceptance for review of bremelanotide NDA
4 June 2018 - PDUFA target action date 23 March 2019. ...
Posted by Michael Wonder on 04 Jun 2018
FDA chief expects agency to play role in overseeing requests for unproven drugs
3 June 2018 - Scott Gottlieb reacts to new ‘Right to Try’ law aimed at weakening FDA’s power in such cases. ...
Posted by Michael Wonder on 04 Jun 2018
FDA wants to shorten new drug monopolies to cut costs
4 June 2018 - In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb ...