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FDA grants Breakthrough Therapy designation to Lynparza in mCRPC
28 January 2016 | By Victoria White
This Lynparza BTD is for the treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer...
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Food and Drug Administration (FDA)
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FDA grants third venetoclax Breakthrough Therapy Designation
28 January 2016 | By Victoria White
The designation is for venetoclax in combination with HMAs for the treatment of patients with untreated AML who are ineligible to receive standard induction therapy...
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FDA to review BLA for Merck’s bezlotoxumab
27 January 2016 | By Victoria White
Bezlotoxumab is designed to neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to C. difficile-associated diarrhoea...
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FDA accepts filing of cardiovascular outcomes for Jardiance
26 January 2016 | By Victoria White
The FDA has accepted a sNDA for Jardiance (empagliflozin) based on cardiovascular risk reduction data from the EMPA-REG OUTCOME trial...
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FDA accepts BLA for Amgen’s Humira biosimilar, ABP 501
26 January 2016 | By Victoria White
Humira (adalimumab) is an anti-TNF-α monoclonal antibody which is approved in many regions for the treatment of several inflammatory diseases...
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Shire resubmits NDA for lifitegrast to the FDA
25 January 2016 | By Victoria White
Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA in October last year...
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Opdivo + Yervoy regimen receives expanded FDA approval
25 January 2016 | By Victoria White
The FDA has approved Opdivo (nivolumab) + Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma...
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FDA approves new Kyprolis combination therapy in multiple myeloma
22 January 2016 | By Victoria White
The FDA has approved the supplemental New Drug Application (sNDA) of Amgen’s Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone...
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FDA grants breakthrough therapy designation to venetoclax combo in CLL
20 January 2016 | By Victoria White
Venetoclax is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis...
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Lilly and Incyte submit NDA for baricitinib to the FDA
Lilly and Incyte have announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).
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Eisai’s lenvatinib receives FDA priority review
18 January 2016 | By Victoria White
The FDA has accepted for Priority Review Eisai’s supplemental New Drug Application for lenvatinib for the potential treatment of patients with renal cell carcinoma...
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FDA grants Orphan Drug Designation to IONIS-HTTRx
5 January 2016 | By Victoria White
IONIS-HTTRx is a Gen. 2.0+ antisense drug in development for the treatment of Huntington's disease...
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FDA approves Uptravi for pulmonary arterial hypertension
23 December 2015 | By Victoria White
Uptravi (selexipag) acts by relaxing muscles in the walls of blood vessels to dilate (open) blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs...
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FDA approves Zurampic for patients with gout
23 December 2015 | By Victoria White
The FDA has approved AstraZeneca’s Zurampic (lesinurad) in combination with xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout...
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FDA grants Breakthrough designation for BI 1482694 in lung cancer
21 December 2015 | By Victoria White
BI 1482694 is Boehringer Ingelheim’s 3rd-generation, epidermal growth factor receptor mutation-specific tyrosine kinase inhibitor...
