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Regulatory Affairs

ONL Therapeutics gets FDA orphan drug designation for ONL1204 to treat retinal detachment The US Food and Drug Administration (FDA) has granted orphan drug designation to ONL Therapeutics' ONL1204 for the treatment of retinal detachment.
Regulatory Affairs > News
Amarantus gets FDA orphan drug designation for Eltoprazine to treat PD-LID Amarantus BioScience has received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
Regulatory Affairs > News FDA halts clinical trial of CTI Biopharma’s blood cancer drug By PBR Staff Writer
The US Food and Drug Administration has put a complete hold on CTI Biopharma’s new blood cancer drug Pacritinib.
Regulatory Affairs > News
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UK health agency rejects Sanofi’s cholesterol drug
By PBR Staff Writer
UK’s National Institute of Health and Clinical Excellence (NICE) has recommended that patients with high-cholesterol should not take Sanofi and Regeneron’s new cholesterol lowering injection Praluent, but backed Amgen’s similar drug Repatha.
Regulatory Affairs > News
US FDA delays decision on Sarepta Therapeutics’ drug to treat muscular dystrophy
By PBR Staff Writer
Sarepta Therapeutics has announced that the US Food and Drug Administration (FDA) will require more time to review its drug for muscular dystrophy.
Regulatory Affairs > News
FDA declines to approve Vertex's Kalydeco in people with cystic fibrosis ages 2 and older
The US Food and Drug Administration (FDA) has declined to approve Vertex Pharmaceuticals' Kalydeco (ivacaftor) in people with cystic fibrosis (CF) ages two and older with one of 23 residual function mutations.
Regulatory Affairs > News
US FDA advisory committee votes in favor for Takeda and Lundbeck's Brintellix
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 to recommend the use of Brintellix (vortioxetine) to treat certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).
Regulatory Affairs > News
FDA expands indication for Merck's Emend nausea and vomiting drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved the use of Merck's single-dose Emend (fosaprepitant dimeglumine) in combination with other antiemetic agents to prevent delayed nausea and vomiting in patients who receive moderately emetogenic chemotherapy (MEC).
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EC approves TAGRISSO to treat patients with EGFR T790M mutation-positive NSCLC
The European Commission (EC) has granted conditional marketing authorisation for AstraZeneca's TAGRISSO (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
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FDA grants fast track designation for Nimbus' NDI-010976 to treat NASH
The US Food and Drug Administration (FDA) has granted Fast Track designation for NDI-010976, Nimbus Therapeutics' liver-targeted allosteric inhibitor of acetyl-CoA carboxylase (ACC), for the treatment of NASH (non-alcoholic steatohepatitis).
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UK regulator approves human gene-editing technique
By PBR Staff Writer
The UK's Human Fertilisation and Embryology Authority (HFEA) has approved a proposal to use new gene editing techniques on human embryos.
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Ariad gets FDA nod to start clinical development of AP32788
By PBR Staff Writer
Ariad Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to start clinical development of AP32788, a tyrosine kinase inhibitor (TKI) designed to address an unmet medical need in a subset of non-small cell lung cancers (NSCLCs).
Regulatory Affairs > News
FDA grants breakthrough therapy designation to Lynparza for prostate cancer
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for AstraZeneca's oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
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