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FDA approves Zegalogue for severe hypoglycemia in pediatric and adult patients with diabetes – Zealand Pharma

Written by | 8 Apr 2021

Zealand Pharma announced that the FDA has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and… read more.

CHMP recommends expanded approval for Saxenda in obesity – Novo Nordisk

Written by | 7 Apr 2021

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda (liraglutide) is… read more.

EMA validates MAA for Trodelvy under accelerated review in triple-negative breast cancer – Gilead Sciences

Written by | 6 Apr 2021

Gilead Sciences announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy) (SG) for the treatment of adult patients with… read more.

EMA validates MAA for relugolix for the treatment of advanced prostate cancer – Myovant Sciences

Written by | 5 Apr 2021

Myovant Sciences announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the… read more.

Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents

Written by | 4 Apr 2021

Pfizer Inc. and BioNTech SE announced that, in a Phase III trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection,… read more.

European Commission grants conditional approval for Nexpovio to treat multiple myeloma – Karyopharm Therapeutics

Written by | 3 Apr 2021

Karyopharm Therapeutics Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Nexpovio (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine,… read more.

Health Canada approves Taltz for pediatric patients with plaque psoriasis – Eli Lilly

Written by | 2 Apr 2021

Health Canada issued a Notice of Compliance for Taltz (ixekizumab), from Eli Lilly, injection, 80 mg/mL, for the treatment of pediatric patients from six to less than 18… read more.

CHMP issues advice on the use of Celltrion’s regdanvimab (CT-P59) for COVID-19 patients in the European Union

Written by | 1 Apr 2021

Celltrion Group announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody… read more.

Keytruda monotherapy is EU approved for adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma – Merck Inc

Written by | 31 Mar 2021

Merck announced that the European Commission (EC) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients aged… read more.

TGA approves use of Trikafta to treat cystic fibrosis F508del mutation in Australia – Vertex

Written by | 30 Mar 2021

Vertex Pharmaceuticals Incorporated announced that the Australian Therapeutic Goods Administration (TGA) has approved the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis (CF) ages 12… read more.

FDA approves supplemental NDA for Exparel for postsurgical local analgesia in pediatric patients – Pacira BioSciences

Written by | 29 Mar 2021

Pacira BioSciences, Inc. announced the FDA has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the Exparel label to include use in patients… read more.

Insulet’s Omnipod 5 automated insulin delivery system improves clinical outcomes in type 1 diabetes

Written by | 28 Mar 2021

Insulet Corporation (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced positive results from the first pivotal trial… read more.

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