Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

Regulatory Affairs

Merck, Pfizer get EC approval for skin cancer drug Bavencio By PBR Staff Writer
Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.
Regulatory Affairs > News
Roche gets EC nod for Gazyvaro to treat advanced follicular lymphoma By PBR Staff Writer
Roche has secured approval from the European Commission (EC) for its Gazyvaro (obinutuzumab) in combination with chemotherapy for the treatment for previously untreated advanced follicular lymphoma.
Regulatory Affairs > News Novartis’ Rydapt approved in Europe for AML and rare blood disorders By PBR Staff Writer
Novartis’ cancer drug Rydapt (midostaurin) has been approved by the European Commission (EC) for a mutated form of acute myeloid leukemia (AML) and certain rare blood disorders.
Regulatory Affairs > News
See more Regulatory Affairs news

Latest Regulatory Affairs News and Insight

View all Regulatory Affairs news or find news targeted to your interests
Novartis’ Rydapt approved in Europe for AML and rare blood disorders
By PBR Staff Writer
Novartis’ cancer drug Rydapt (midostaurin) has been approved by the European Commission (EC) for a mutated form of acute myeloid leukemia (AML) and certain rare blood disorders.
Regulatory Affairs > News
Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery
Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
Regulatory Affairs > News
Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea
Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Regulatory Affairs > News
GSK, Innoviva get FDA nod for COPD treatment Trelegy Ellipta
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva have secured approval from the US Food and Drug Administration (FDA) for once-daily and single inhaler triple therapy, Trelegy Ellipta, to treat patients with chronic obstructive pulmonary disease (COPD).
Regulatory Affairs > News
FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment
The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.
Regulatory Affairs > News
PQG 40th Anniversary – Meet NSF, 9-11 October, Milton Keynes, UK
To celebrate their 40th anniversary, the Pharmaceutical Quality Group (PQG) are holding an anniversary dinner on the evening of Monday, 9 October and a three-day meeting from 9 to 11 October at the Hilton Hotel in Milton Keynes, UK.
Regulatory Affairs > Press Releases
NSF: The Journal Issue 39 - Simplicity - Critical For Success In Your Quality System
This edition focuses on simplicity in relation to your pharmaceutical quality system.
Regulatory Affairs > Press Releases
SHL to Showcase Latest Innovations at PDA Universe of Pre-filled Syringes & Injection Devices
SHL Group is to present its range of new devices and innovative technologies at the 2017 Parenteral Drug Association Universe of Pre-filled Syringes and Injection Devices.
Regulatory Affairs > Press Releases
Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
Regulatory Affairs > News
View all Regulatory Affairs news or find news targeted to your interests