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31-45 of 3445 results
Innocoll receives refusal to file letter from FDA for post-surgical pain candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued a Refuse-to-File letter halting further review of Innocoll's new drug application (NDA) for its post-surgical pain candidate Xaracoll.
Regulatory Affairs > News
Novo Nordisk gets FDA approval for Tresiba's use in children
Novo Nordisk secured approval from the US Food and Drug Administration (FDA) for an expanded use for Tresiba (insulin degludec) injection to improve glycemic control in children and adolescents with both type 1 and type 2 diabetes.
Regulatory Affairs > News
Pfizer announces EC approval for Nimenrix in infants six weeks of age and older
Pfizer has secured approval from the European Commission (EC) for an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age.
Regulatory Affairs > News
FDA drops boxed warning on Pfizer's smoking cessation drug
The U.S. Food and Drug Administration (FDA) has approved updates to Pfizer’s CHANTIX (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events.
Regulatory Affairs > News
Intercept's Ocaliva gets EC approval to treat primary biliary cholangitis
Intercept Pharmaceuticals has secured conditional approval from the European Commission (EC) for Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Regulatory Affairs > News
European Commission approves Ferring's REKOVELLE (follitropin delta)
Ferring Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for REKOVELLE (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), intended to be used in controlled ovarian stimulation for developing multiple follicles in women undergoing assisted reproductive technologies (ART), like an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Regulatory Affairs > News
FDA approves Synjardy XR tablets for adults with type 2 diabetes
The US Food and Drug Administration (FDA) has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets to treat adults with type 2 diabetes.
Regulatory Affairs > News
European Commission approves new indication for Novartis’ Lucentis eye drug
By PBR Staff Writer
The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions.
Regulatory Affairs > News
UK's CMA fines Pfizer and Flynn Pharma for epilepsy drug price hike
By PBR Staff Writer
Pfizer and Flynn Pharma have been fined a record amount for abusing their dominant position in the UK by charging excessive and unfair prices for an anti-epilepsy drug.
Regulatory Affairs > News
Amgen and Allergan submit bevacizumab biosimilar application to EMA
Amgen and Allergan have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab).
Regulatory Affairs > News
GSK seeks EU approval for inhaled triple combo COPD therapy
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking approval in Europe for once-daily closed triple combination therapy to treat chronic obstructive pulmonary disease (COPD) patients.
Regulatory Affairs > News
FDA approves cardiovascular indication for Jardiance
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a new indication for Jardiance (empagliflozin), a type 2 diabetes treatment from Boehringer Ingelheim and Eli Lilly.
Regulatory Affairs > News
Bristol-Myers Squibb’s Opdivo approved for Hodgkin lymphoma in Europe
By PBR Staff Writer
Bristol-Myers Squibb has secured approval from the European Commission for Opdivo (nivolumab) to treat adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Regulatory Affairs > News
Teva’s Trisenox approved in Europe for first line treatment of APL
By PBR Staff Writer
The European Commission has expanded the scope of Teva Pharmaceutical Industries’ Trisenox, approving its use to treat patients with newly diagnosed acute promyelocytic leukaemia (APL).
Regulatory Affairs > News
FDA extends indication for GSK’s FluLaval Quadrivalent influenza vaccine in infants
By PBR Staff Writer
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) to expand FluLaval Quadrivalent (influenza vaccine) indication.
Regulatory Affairs > News
31-45 of 3445 results