Regulatory Affairs

Regulatory Affairs News

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1-15 of 3712 results
FDA advisory committee votes against approving GSK’s mepolizumab to treat COPD
By PBR Staff Writer
The Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending GlaxoSmithKline’s (GSK) mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.
Regulatory Affairs > News
Futura Medical seeks UK approval for topical pain relief product
Futura Medical announced that its UK commercialisation partner for TPR100, one of the company's novel topical pain relief products, has filed the product's marketing authorisation application with the UK Medicines and Healthcare products Regulatory Agency.
Regulatory Affairs > News
Agios Pharmaceuticals secures FDA nod for leukemia treatment Tibsovo
By PBR Staff Writer
Agios Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Tibsovo (ivosidenib) to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.
Regulatory Affairs > News
FDA accepts Immunomedics’ BLA and grants priority review for Sacituzumab Govitecan to treat metastatic triple-negative breast cancer
Immunomedics announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for filing and granted priority review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease.
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Indivior wins US court order blocking Dr. Reddy's sale of generic opioid treatment
By PBR Staff Writer
A US court has approved Indivior’s preliminary injunction (PI) preventing Dr. Reddy's Laboratories (DRL) from marketing of generic opioid addiction treatment.
Regulatory Affairs > News
SIGA Technologies gets FDA nod for TPOXX to treat smallpox
By MDBR Staff Writer
SIGA Technologies has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.
Regulatory Affairs > News
FDA grants priority review to Merck’s sBLA for Keytruda to treat advanced hepatocellular carcinoma
Merck announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking approval for anti-PD-1 therapy, Keytruda, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC).
Regulatory Affairs > News
BioCryst terminates merger deal with Idera Pharmaceuticals
By PBR Staff Writer
BioCryst Pharmaceuticals has failed to get approval from the stockholders for its merger deal with Idera Pharmaceuticals.
Regulatory Affairs > News
Amryt secures funding approval from NHS England for bad cholesterol treatment
By PBR Staff Writer
Biopharmaceutical firm Amryt has secured approval for funding from NHS England for its bad cholesterol treatment, Lojuxta (lomitapide).
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EMA recalls certain heart drugs containing valsartan over safety fears
By PBR Staff Writer
The European Medicines Agency (EMA) has recalled certain heart drugs containing valsartan across the European Union (EU) over possible contamination with a cancer-causing substance.
Regulatory Affairs > News
Alliance Pharma secures UK approval for nausea drug Diclectin
By PBR Staff Writer
Alliance Pharma has secured approval for Diclectin in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of nausea and vomiting in pregnant women.
Regulatory Affairs > News
EC approves expanded indication for BMS’ Sprycel
Bristol-Myers Squibb (BMS) has announced that the European Commission (EC) has expanded the indication for Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation.
Regulatory Affairs > News
EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.
Regulatory Affairs > News
ASLAN Pharmaceuticals submits clinical trial authorisation application for first in man studies for ASLAN004
ASLAN Pharmaceuticals has submitted a clinical trial authorisation application with the Singapore Health Sciences Authority (HSA) to initiate a phase 1 trial of ASLAN004.
Regulatory Affairs > News
Elite secures FDA approval for generic Percocet pain tablets
Elite Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets.
Regulatory Affairs > News
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