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RSS FeedPosted by Michael Wonder on 02 Jun 2020
Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids
1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 02 Jun 2020
AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma
1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...
Posted by Michael Wonder on 02 Jun 2020
FDA accepts Shionogi’s supplemental new drug application with priority review for Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 June 2020 - Shionogi today announced the U.S. FDA has accepted the company’s supplemental new drug application for Fetroja ...
Posted by Michael Wonder on 02 Jun 2020
Lynparza recommended for approval in EU by CHMP for BRCA mutated metastatic pancreatic cancer
1 June 2020 - Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting. ...
Posted by Michael Wonder on 01 Jun 2020
AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis
1 June 2020 - Submissions supported by two Phase 3 studies in which Rinvoq demonstrated improved joint outcomes, physical function and ...
Posted by Michael Wonder on 01 Jun 2020
Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease
1 June 2020 - New Brilinta indication expands treatment to high-risk coronary patients without a history of stroke or heart ...
Posted by Michael Wonder on 01 Jun 2020
CytoDyn files request with FDA for priority review of BLA for first approval
1 June 2020 - If granted, the FDA is expected to take action on the Company’s BLA within six months. ...
Posted by Michael Wonder on 01 Jun 2020
Lilly's Taltz (ixekizumab) is the first IL-17A antagonist to receive U.S. FDA approval for the treatment of non-radiographic axial spondyloarthritis
1 June 2020 - Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis, also known ...
Posted by Michael Wonder on 01 Jun 2020
Zionexa USA and PETNET Solutions announce FDA approval of Cerianna (Fluoroestradiol F 18)
27 May 2020 - Zionexa USA and PETNET Solutions have announced that the FDA has approved Cerianna (fluoroestradiol F 18) injection ...
Posted by Michael Wonder on 01 Jun 2020
U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis
27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...
Posted by Michael Wonder on 01 Jun 2020
Orphazyme initiates rolling submission of new drug application for arimoclomol with US FDA in Niemann-Pick disease type C
29 May 2020 - EMA marketing authorisation application submission expected in H2 2020. ...
Posted by Michael Wonder on 01 Jun 2020
CHMP issues positive opinion to extend Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes
29 May 2020 - Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation ...
Posted by Michael Wonder on 01 Jun 2020
Menlo Therapeutics receives FDA approval of Zilxi (minocycline) 1.5 % topical foam, the first topical minocycline treatment for rosacea
29 May 2020 - Zilxi now approved for inflammatory lesions of rosacea in adults. ...
Posted by Michael Wonder on 01 Jun 2020
Boehringer Ingelheim receives positive CHMP opinion for a third nintedanib indication in pulmonary fibrosis
29 May 2020 - The opinion is for the treatment of adults with other chronic fibrosing interstitial lung diseases with a ...
Posted by Michael Wonder on 01 Jun 2020
Takeda receives positive CHMP opinion for pre-filled syringe presentation of Takhzyro (lanadelumab) for use as a preventive treatment for hereditary angioedema attacks
29 May 2020 - Validation of type II variation will allow Takeda to commence launches in Europe later this year. ...