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136-150 of 3464 results
Novartis' Afinitor drug secures EU approval for GI, lung neuroendocrine tumors
By PBR Staff Writer
The European Commission has approved Novartis' Afinitor drug to treat various types of advanced gastrointestinal (GI) and lung neuroendocrine tumors (NET).
Regulatory Affairs > News
European Commission approves Imbruvica for first-line treatment of CLL patients
By PBR Staff Writer
The European Commission (EC) has approved Imbruvica (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
FDA approves Allergan's TEFLARO for pediatric patients
The U.S. Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil), granting new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.
Regulatory Affairs > News
Teva receives CRL from FDA in response to SD-809 NDA
The US Food and Drug Administration (FDA) has asked Teva Pharmaceutical Industries to examine blood levels of several metabolites in response to the company's new drug application (NDA) for SD-809 tablets to treat chorea associated Huntington disease (HD).
Regulatory Affairs > News
European Commission approves Samsung Bioepis’ Remicade biosimilar
By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Flixabi, a biosimilar version of Johnson & Johnson's Remicade (infliximab) rheumatoid arthritis drug.
Regulatory Affairs > News
European Commission approves Strimvelis to treat immune deficiency disorder in children
By PBR Staff Writer
The European Commission (EC) has approved Strimvelis, an ex-vivo stem cell gene therapy for the treatment of a very rare disorder called ADA-SCID, or severe combined immunodeficiency due to adenosine deaminase deficiency.
Regulatory Affairs > News
FDA approves Zinbryta to treat relapsing forms of multiple sclerosis
By PBR Staff Writer
Biogen and AbbVie have secured approval from the US Food and Drug Administration for Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (MS).
Regulatory Affairs > News
Titan Pharmaceuticals wins FDA approval for Probuphine to treat opioid dependence
The US Food and Drug Administration has approved Titan Pharmaceuticals' Probuphine (buprenorphine) implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.
Regulatory Affairs > News
FDA approves CSL Behring's single-chain Afstyla for hemophilia A
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved CSL Behring's Afstyla [Antihemophilic Factor (Recombinant) Single Chain] to treat adults and children with hemophilia A.
Regulatory Affairs > News
FDA expands indication for Janssen Pharmaceuticals’ Invokamet diabetes drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded indication for Janssen Pharmaceuticals’ Invokamet diabetes medication.
Regulatory Affairs > News
European Commission approves Darzalex for multiple myeloma
By PBR Staff Writer
The European Commission has granted conditional approval to Darzalex (daratumumab) to treat adults with relapsed and refractory multiple myeloma.
Regulatory Affairs > News
European regulator accepts Pfizer's Trumenba marketing authorization application for review
The European Medicines Agency (EMA) has accepted Pfizer's marketing authorization application to review for Trumenba (Meningococcal Group B Vaccine), which was developed to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and above.
Regulatory Affairs > News
UK NICE rejects Roche’s Perjeta breast cancer drug
By PBR Staff Writer
UK’s National Institute for Health and Care Excellence (NICE) has rejected Roche’s Perjeta treatment for breast cancer claiming that it is pricey and would not offer value for money.
Regulatory Affairs > News
FDA approves Genentech's Atezolizumab for advanced urothelial carcinoma
By PBR Staff Writer
Genentech has secured approval from the US Food and Drug Administration for its Tecentriq (atezolizumab) to treat the most common type of bladder cancer, dubbed urothelial carcinoma.
Regulatory Affairs > News
EC grants marketing authorization for Actelion's Uptravi to treat pulmonary arterial hypertension
The European Commission (EC) has granted marketing authorization in the EU for Actelion's orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag) to treat pulmonary arterial hypertension.
Regulatory Affairs > News
136-150 of 3464 results