Regulatory Affairs

Regulatory Affairs News

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1-15 of 3708 results
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).
Regulatory Affairs > News
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
Cyprium Therapeutics’ CUTX-101 gets FDA fast track designation to treat classic Menkes disease
Fortress Biotech announced that the US Food and Drug Administration (FDA) has granted fast track designation to Cyprium Therapeutics Copper Histidinate, also referred to as CUTX-101, for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.
Regulatory Affairs > News
AstraZeneca gets regulatory approvals for two cancer drugs in Japan
By PBR Staff Writer
AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.
Regulatory Affairs > News
FDA approves Array BioPharma’s Braftovi/Mektovi melanoma combo treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Array BioPharma’s oral combination treatment of Braftovi (encorafenib) capsules and Mektovi (binimetinib) tablets for a serious and deadly type of skin cancer.
Regulatory Affairs > News
FDA approves Achaogen’s Zemdri to treat adults with cUTI
By PBR Staff Writer
Achaogen has secured approval from the US Food and Drug Administration (FDA) for its Zemdri (plazomicin) to treat adults with complicated urinary tract infections (cUTI).
Regulatory Affairs > News
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