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RSS FeedPosted by Michael Wonder on 09 May 2018
FDA grants fast track designation to Debiopharm's Debio 1347 for the treatment of patients with unresectable or metastatic tumours with a specific FGFR gene alteration
8 May 2018 - Debiopharm announced today that the U.S. FDA has granted fast track designation to Debio 1347, an ...
Posted by Michael Wonder on 08 May 2018
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in newly diagnosed multiple myeloma
7 May 2018 - First approval for Darzalex in a frontline indication. ...
Posted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 06 May 2018
Ferring signs global agreement to commercialise novel gene therapy for bladder cancer patients
3 May 2018 - The US FDA has granted fast track and breakthrough therapy designations to rAd-IFN/Syn3. ...
Posted by Michael Wonder on 05 May 2018
FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
4 May 2018 - The U.S. FDA approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid ...
Posted by Michael Wonder on 03 May 2018
Cellectar receives rare paediatric disease designation for CLR 131 to treat neuroblastoma
2 May 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 02 May 2018
Too many cancer drugs? Crowded market gives investors pause
2 May 2018 - In London’s world-famous Great Ormond Street children’s hospital, Dr. Karin Straathof is excited about a new ...
Posted by Michael Wonder on 01 May 2018
FDA grants priority review to Merck’s sBLA for Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy based on results from Phase 3 KEYNOTE-189 trial as first-line treatment of metastatic non-squamous NSCLC
30 April 2018 - U.S. FDA has set a PDUFA date of 23 September 2018. ...
Posted by Michael Wonder on 30 Apr 2018
Novartis receives FDA approval of Tafinlar and Mekinist for adjuvant treatment of BRAF V600-mutant melanoma
30 April 2018 - New indication represents a new treatment option for patients in the US with BRAF mutation-positive melanoma at ...
Posted by Michael Wonder on 30 Apr 2018
FDA to conduct priority review of cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
30 April 2018 - The U.S. FDA has accepted priority review the biologics license application for cemiplimab for the treatment ...
Posted by Michael Wonder on 27 Apr 2018
The breakthrough therapy designation for promising cancer drugs is good for patients
27 April 2018 - One exciting component of the FDA Safety and Innovation Act was the creation of the breakthrough ...
Posted by Michael Wonder on 26 Apr 2018
Astellas submits new drug applications for approval of gilteritinib for the treatment of FLT3 mutation positive relapsed or refractory acute myeloid leukaemia
24 April 2018 - Astellas Pharma today announced that it submitted on March 23, 2018, a new drug application (NDA) for ...
Posted by Michael Wonder on 25 Apr 2018
Efficacy, safety, and regulatory approval of FDA–designated breakthrough and non-breakthrough cancer medicines
24 April 2018 - The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer provides update on proposed trastuzumab biosimilar
23 April 2018 - Pfizer today announced that it received a complete response letter from the United States FDA in response ...
Posted by Michael Wonder on 21 Apr 2018
U.S. FDA grants fast track designation for Polyphor's innovative immuno-oncology candidate balixafortide in combination with eribulin as third-line therapy for metastatic breast cancer
19 April 2018 - Polyphor announced today that the U.S. FDA has granted fast track designation for its novel immuno-oncology candidate ...