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Regulatory Affairs

Novartis gets EC approval for Tasigna to treat Ph+ CML-CP in children By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for its Tasigna (nilotinib) to treat pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Regulatory Affairs > News
Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Ontruzant, a biosimilar version of Genentech’s Herceptin (trastuzumab), for the treatment of breast cancer in early and metastatic stages and also for metastatic gastric cancer.
Regulatory Affairs > News Roche’s Hemlibra secures FDA approval for hemophilia A with inhibitors By PBR Staff Writer
Roche’s Hemlibra (emicizumab-kxwh) has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have factor VIII inhibitors.
Regulatory Affairs > News
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Lynne Byers and David Waddington Join NSF International’s Pharma Biotech Service in Europe
New leaders each bring over 30 years of management and quality assurance experience to NSF International
Regulatory Affairs > Press Releases
Ultragenyx’s Mepsevii secures FDA approval for Mucopolysaccharidosis VII
By PBR Staff Writer
Ultragenyx Pharmaceutical’s enzyme replacement therapy Mepsevii (vestronidase alfa) has secured approval from the US Food and Drug Administration (FDA) for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome) in both children and adults.
Regulatory Affairs > News
AstraZeneca gets FDA nod for Fasenra to treat severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca, along with its wholly owned subsidiary MedImmune, has secured approval from the US Food and Drug Administration (FDA) for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.
Regulatory Affairs > News
US FDA approves first drug with digital ingestion tracking system
By PBR Staff Writer
Otsuka Pharmaceutical has secured approval from the US Food and Drug Administration for its Abilify MyCite (aripiprazole tablets with sensor), an antipsychotic drug that has an embedded sensor to digitally track if patients have ingested their medication.
Regulatory Affairs > News
Sprycel approval expanded to include treatment of children with Ph+ CML in chronic phase
The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Regulatory Affairs > News
EMA’s CHMP recommends Amgen and Allergan’s ABP 215 to treat certain types of cancer
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to approve ABP 215 for the treatment of certain types of cancer.
Regulatory Affairs > News
Merck gets FDA approval for Prevymis to prevent CMV infection and disease in adult allogeneic stem cell transplant patients
Merck has announced that the US Food and Drug Administration (FDA) has approved Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion.
Regulatory Affairs > News
Roche secures FDA approvals for cancer drugs Zelboraf and Alecensa
By PBR Staff Writer
Roche has secured approvals from the US Food and Drug Administration (FDA) for its blood cancer drug Zelboraf (vemurafenib) and lung cancer drug Alecensa (alectinib).
Regulatory Affairs > News
FDA lifts clinical hold on Cellectis phase 1 trials with UCART123 in AML and BPDCN
The US Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Regulatory Affairs > News
Novartis seeks EMA approval for CTL019 for two indications
By PBR Staff Writer
Novartis is seeking approval from the European Medicines Agency (EMA) for its CTL019 (Kymriah or tisagenlecleucel) to treat two forms of blood cancer.
Regulatory Affairs > News
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