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76-90 of 3478 results
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
Amgen’s Parsabiv approved in Europe for sHPT treatment in adults with CKD
By PBR Staff Writer
Amgen has secured approval from the European Commission (EC) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Regulatory Affairs > News
Pfizer secures EU approval for Ibrance breast cancer drug
By PBR Staff Writer
Pfizer has secured approval from the European Commission (EC) for Ibrance (palbociclib) to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
Regulatory Affairs > News
FDA approves Gilead’s Vemlidy to treat chronic hepatitis B virus infection
The US Food and Drug Administration (FDA) has approved Gilead Sciences' Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
Regulatory Affairs > News
FDA approves Amgen’s Enbrel to treat children with plaque psoriasis
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for the expanded use of Enbrel (etanercept) to treat children with chronic moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
FDA approves Lilly's LARTRUVO in combination with doxorubicin for soft tissue sarcoma
Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Regulatory Affairs > News
Shire's ONIVYDE approved in Europe for pancreatic cancer
The European Commission (EC) has granted marketing authorization for Shire's ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate), also known as nal-IRI or MM-398, to treat metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy.
Regulatory Affairs > News
FDA approves Genentech’s Tecentriq for metastatic non-small cell lung cancer
Roche’s subsidiary Genentech has secured approval from the US Food and Drug Administration (FDA) for cancer immunotherapy Tecentriq (atezolizumab) to treat people with metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA's ODE-I denies PTC Therapeutics' DMD drug appeal
The Office of Drug Evaluation I (ODE-I) of the US Food and Drug Administration (FDA) denied PTC Therapeutics' first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products (DNP) on February 22, 2016 regarding the company's New Drug Application (NDA) for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
Regulatory Affairs > News
Trevi Therapeutics unveils positive results from phase 2 trial in prurigo nodularis
Trevi Therapeutics, which is developing oral Nalbuphine®ER for chronic pruritus conditions, announced positive results from its phase 2 trial for the treatment of moderate to severe prurigo nodularis.
Regulatory Affairs > News
Lundbeck wins FDA approval for intravenous Carnexiv for temporary treatment of seizures
By PBR Staff Writer
Pharmaceutical firm Lundbeck has secured approval from the US Food and Drug Administration (FDA) for Carnexiv (carbamazepine) injection as intravenous short-term replacement therapy for several seizure types.
Regulatory Affairs > News
FDA approves Orexo’s low-dose Zubsolv to treat opioid dependence
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a new low dose version of Orexo's treatment for opioid dependence.
Regulatory Affairs > News
European Commission approves transfer of marketing authorisation for Alprolix to Sobi
The European Commission (EC) has approved the transfer of the marketing authorization for Alprolix (eftrenonacog alfa), a recombinant clotting factor therapy developed for the treatment of haemophilia B, from Biogen to Swedish Orphan Biovitrum (Sobi), making Sobi the marketing authorization holder (MAH) in the EU.
Regulatory Affairs > News
76-90 of 3478 results