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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
FDA approves Janssen Biotech's STELARA for Crohn’s disease
The US Food and Drug Administration (FDA) has approved Janssen Biotech's STELARA (ustekinumab) to treat moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
Regulatory Affairs > News
FDA approves expanded use of Novartis’ Ilaris to treat three rare periodic fever syndromes
By PBR Staff Writer
Novartis has secured three new approvals from the US Food and Drug Administration (FDA) for the expanded use of Ilaris (canakinumab) to treat three rare types of Periodic Fever Syndromes.
Regulatory Affairs > News
Sanaria's preventative vaccine for malaria gets FDA fast track designation
The US Food and Drug Administration (FDA) has granted Fast Track designation for Sanaria's preventative vaccine for malaria, Sanaria PfSPZ Vaccine.
Regulatory Affairs > News
46-60 of 3445 results