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RSS FeedPosted by Michael Wonder on 14 Jun 2018
scPharmaceuticals receives complete response letter from the FDA for Furoscix
13 June 2018 - scPharmaceuticals today announced the Company received a complete response letter from the U.S. FDA regarding the ...
Posted by Michael Wonder on 14 Jun 2018
FDA grants priority review to Merck’s supplemental biologics license application for Gardasil 9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases
13 June 2018 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 14 Jun 2018
Mylan provides statement on generic Advair Diskus
13 June 2018 - On the afternoon of June 13, 2018, Mylan received an update from the U.S. FDA concerning ...
Posted by Michael Wonder on 14 Jun 2018
FDA approves Merck’s Keytruda (pembrolizumab) for treatment of refractory or relapsed primary mediastinal large B-cell lymphoma
13 June 2018 - Keytruda is the first anti-PD-1 therapy approved for adult and paediatric patients with refractory PMBCL or who ...
Posted by Michael Wonder on 14 Jun 2018
U.S. FDA approves moxidectin for the treatment of river blindness
13 June 2018 - Medicines Development for Global Health and the World Health Organisation Special Programme for Research and Training in ...
Posted by Michael Wonder on 13 Jun 2018
Sunovion announces FDA acceptance of new drug application for apomorphine sublingual film
12 June 2018 - Sunovion seeks approval for apomorphine sublingual film for the on-demand treatment of OFF episodes associated with Parkinson’s ...
Posted by Michael Wonder on 13 Jun 2018
FDA approves Genentech’s Avastin (bevacizumab) plus chemotherapy as a treatment for women with advanced ovarian cancer following initial surgery
13 June 2018 - Avastin is now approved for ten distinct uses across six different types of cancer in the United ...
Posted by Michael Wonder on 13 Jun 2018
AMCP applauds FDA for final guidance on payer and manufacturer communications to improve patient access to emerging therapies
13 June 2018 - The Academy of Managed Care Pharmacy commends the U.S. FDA for issuing final guidance that clarifies ...
Posted by Michael Wonder on 13 Jun 2018
Mylan CEO promises Neulasta biosimilar will offer "significant savings" for patients
12 June 2018 - Nearly two years after taking tremendous heat for the rising cost of EpiPens, pharmaceutical giant Mylan ...
Posted by Michael Wonder on 13 Jun 2018
FDA grants rare paediatric disease designation to A4250; Albireo eligible to apply for priority review voucher
12 June 2018 - Albireo Pharma a clinical-stage orphan paediatric liver disease company developing novel bile acid modulators, today announced the ...
Posted by Michael Wonder on 13 Jun 2018
Nordic Nanovector announces Betalutin has been granted fast track designation in the US for follicular lymphoma
12 June 2018 - Nordic Nanovector announces that the US FDA has granted fast track designation to Betalutin (177Lu-lilotomab satetraxetan) ...
Posted by Michael Wonder on 13 Jun 2018
RegenxBio receives FDA fast track designation for RGX-111 gene therapy for the treatment of mucopolysaccharidosis type I
12 June 2018 - Phase I clinical trial expected to enroll children and adults with MPS I. ...
Posted by Michael Wonder on 13 Jun 2018
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
12 June 2018 - Keytruda now first anti-PD-1 therapy approved for patients with advanced cervical cancer and disease progression on or ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
12 June 2018 - The increase in serious antimicrobial drug resistant infections is a critical public health concern and a ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new efforts to advance medical product communications to support drug competition and value-based health care
12 June 2018 - We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed ...