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RSS FeedPosted 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4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...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 ...
Posted by Michael Wonder on 04 Jun 2018
Peptilogics receives qualified infectious disease product designation from FDA for lead compound PLG0206 as a treatment for prosthetic joint infection
2 June 2018 - Builds on PLG0206 studies published in Nature Scientific Reports. ...
Posted by Michael Wonder on 03 Jun 2018
FDA chief outlines new ways to speed cancer drug approvals
2 June 2018 - The U.S. FDA is taking steps to streamline the approval process for cancer drugs, reviewing clinical ...
Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license ...
Posted by Michael Wonder on 02 Jun 2018
FDA approves Olumiant (baricitinib) 2 mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis
1 June 2018 - The approval of Olumiant is based on the Phase 3 clinical trial program that demonstrated efficacy for ...
Posted by Michael Wonder on 01 Jun 2018
Idelvion newly approved 3,500 IU vial to provide convenience to patients using larger volumes
31 May 2018 - New vial option delivers on CSL Behring’s promise to enhance current treatments and provide more alternatives to ...
Posted by Michael Wonder on 01 Jun 2018
Nektar Therapeutics announces submission of a new drug application to the U.S. FDA for NKTR-181, a first-in-class investigational opioid to treat chronic low back pain in adult patients new to opioid therapy
31 May 2018 - Nektar Therapeutics today announced submission of a new drug application to the U.S. FDA for NKTR-181, a ...
Posted by Michael Wonder on 01 Jun 2018
Curis announces FDA fast track designation for fimepinostat (CUDC-907) development in patients with relapsed or refractory diffuse large B-cell lymphoma
31 May 2018 - Curis announced today that the U.S. FDA has granted fast track designation for the development of fimepinostat ...