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Regulatory Affairs

Perrigo secures FDA approval for generic version of Ofirmev acetaminophen injection Perrigo has received final US Food and Drug Administration (FDA) approval for the generic version of Mallinckrodt Pharmaceuticals' Ofirmev (acetaminophen) injection 1000 mg/100 mL.
Regulatory Affairs > News
FDA approves expanded label for emphysema treatment Glassia By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded label for self-infusion of Glassia to treat emphysema due to serious Alpha-1 Antitrypsin (AAT) deficiency.
Regulatory Affairs > News FDA approves higher dosage strength Orfadin capsule for HT-1 treatment By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a higher strength 20mg capsule of Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinosne) to treat Hereditary Tyrosinaemia type-1 (HT-1).
Regulatory Affairs > News
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FDA approves Espero Pharmaceuticals’ Gonitro sublingual powder for angina
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Espero Pharmaceuticals’ Gonitro (nitroglycerin) sublingual powder, which is indicated to provide acute relief for an attack of angina pectoris due to coronary artery disease.
Regulatory Affairs > News
ViiV Healthcare wins FDA approval to lower weight limit for dolutegravir HIV drug in children and adolescents
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s supplemental new drug application to reduce the weight limit for dolutegravir to treat HIV-1 in children and adolescents.
Regulatory Affairs > News
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
DCGI gives limited approval to market first Allogeneic cell therapy product in India
The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease.
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
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