Regulatory Affairs

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Alnylam signs settlement agreement with Dicerna to resolve trade secret misappropriation claims
Alnylam Pharmaceuticals has entered into a settlement agreement with Dicerna Pharmaceuticals to resolve trade secret misappropriation claims against Dicerna, and counterclaims asserted by Dicerna, in pending litigation in the Superior Court of Middlesex County, Massachusetts.
Regulatory Affairs > News
FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors
By PBR Staff Writer
Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.
Regulatory Affairs > News
BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.
Regulatory Affairs > News
FDA approves Clovis’ Rubraca for recurrent ovarian cancer
The US Food and Drug Administration (FDA) has approved Clovis Oncology’s Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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Indivior files patent lawsuits against Teva, Dr Reddy's and others
Indivior has filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen and Teva for infringement of United States Patent No. 9,931,305 (the '305 patent) relating to their respective proposed generic versions of the company's Suboxone (buprenorphine and naloxone) sublingual film product.
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Proteostasis’ triple combination program secures FDA fast track status for cystic fibrosis
Proteostasis Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its triple combination program to treat cystic fibrosis.
Regulatory Affairs > News
EMA to review cemiplimab for treatment of advanced cutaneous squamous cell carcinoma
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.
Regulatory Affairs > News
US and European regulators accept AstraZeneca’s applications for cancer treatments
By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).
Regulatory Affairs > News
FDA rejects Alkermes’ NDA for antidepressant drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Alkermes’ new drug application (NDA) for antidepressant drug, ALKS 5461.
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FDA approves new indication for Amgen’s leukemia drug Blincyto
The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children.
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Daiichi Sankyo’s DS-8201 gets SAKIGAKE designation in Japan for gastric cancer
The Japan Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE Designation to Daiichi Sankyo’s investigational HER2-targeting antibody drug conjugate (ADC) DS-8201 for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer.
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Fennec Pharmaceuticals' Pedmark gets FDA breakthrough status
By PBR Staff Writer
Fennec Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Pedmark to prevent cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
Regulatory Affairs > News
Seattle Genetics, Astellas get FDA breakthrough therapy designation for enfortumab vedotin locally advanced or metastatic urothelial cancer
Seattle Genetics, and Astellas Pharma have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for enfortumab vedotin, an antibody-drug conjugate (ADC), to treat patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).
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Soligenix gets orphan drug designation from European Commission for RiVax to prevent Ricin poisoning
The European Commission has granted orphan drug designation to the Soligenix recombinant modified ricin toxin A-chain subunit (the active pharmaceutical ingredient in RiVax) for the prevention of ricin poisoning.
Regulatory Affairs > News
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