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Nektar submits IND for NKTR-214 to treat solid tumours
8 October 2015 | By Victoria White
NKTR-214 is a CD122-biased immune-stimulatory cytokine that is designed to stimulate the expansion and maintenance of CD8-positive effector T-cells...
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U.S. Food and Drug Administration (FDA)
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FDA grants orphan drug designation to BLU-554
30 September 2015 | By Victoria White
BLU-554, an exquisitely selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), is currently being evaluated in a Phase 1 clinical trial in patients with advanced hepatocellular carcinoma...
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Blueprint Medicines to advance BLU-285 in Phase 1 trial for systemic mastocytosis
10 September 2015 | By Victoria White
BLU-285 is a potent and highly selective inhibitor of the KIT D816V mutant, the primary driver of disease in more than 94% of systemic mastocytosis patients...
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Positive topline results from brincidofovir smallpox study
24 July 2015 | By Victoria White
Chimerix has announced that its investigational antiviral brincidofovir showed a survival benefit in a pivotal study of an animal model for smallpox...
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Regen BioPharma reports successful dosing of HemaXellerate in FDA-requested GLP animal study
10 July 2015 | By Victoria White
Regen BioPharma has reported the successful dosing of mice lacking an immune system in a safety and tolerability study with HemaXellerate...
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FDA awards Isarna orphan drug designation for ISTH0036 to improve glaucoma treatment outcome
10 June 2015 | By Victoria White
Isarna Therapeutics has announced that the Food and Drug Administration (FDA) has granted orphan drug designation for ISTH0036...
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FDA Grants Orphan Status for ATX-F8-117 for the treatment of haemophilia A patients in the US
9 June 2015 | By Victoria White
Apitope’s product candidate ATX-F8-117 has been granted Orphan Drug Status by the FDA for the treatment of patients with haemophilia A in the US...
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FDA and EMA grants orphan drug designation to recAP for the treatment of hypophosphatasia
9 June 2015 | By Victoria White
AM‐Pharma has announced that the FDA and EMA have both granted orphan designation status to recAP for the treatment of hypophosphatasia...
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FDA grants QIDP and Fast Track Designations to CD101 IV for the treatment of candidemia
11 May 2015 | By Victoria White
Cidara Therapeutics has announced that the FDA has designated the Company’s lead antifungal product candidate, CD101 IV, as a QIDP with Fast Track status...
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ReNeuron gets approval to start a Phase I/II clinical trial in the US in retinitis pigmentosa
5 May 2015 | By Victoria White
ReNeuron has received approval from the FDA to commence a Phase I/II clinical trial in the US with its hRPC therapy candidate for retinitis pigmentosa...
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FDA encourages manufacturers to develop abuse-deterrent drugs
2 April 2015 | By Victoria White
The U.S. FDA has issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties...
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Pfizer to Acquire InnoPharma, Inc.
17 July 2014 | By Pfizer
Pfizer Inc. and InnoPharma, Inc. announced that they have entered into an agreement under which Pfizer will acquire InnoPharma...
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Teva reports positive results from pivotal Phase III study to evaluate hydrocodone bitartrate extended-release tablets (CEP-33237)
30 April 2014 | By Teva
Data provides promise for a twice-daily, acetaminophen-free hydrocodone designed with potential abuse-deterrent properties...