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Farxiga approved in the US for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes – AstraZeneca

Written by | 3 May 2021

AstraZeneca’s Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage… read more.

CHMP recommends approval of Enspryng for neuromyelitis optica spectrum disorder – Roche

Written by | 2 May 2021

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Enspryng (satralizumab) as the first subcutaneous treatment option… read more.

Protected: FDA grants accelerated approval for Jemperli in endometrial cancer – GSK

Written by | 1 May 2021

There is no excerpt because this is a protected post.

EU CHMP recommends approval of Onureg for acute myeloid leukemia – Bristol Myers Squibb

Written by | 30 Apr 2021

Bristol Myers Squibb has announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Onureg (azacitidine tablets; CC-486) as a… read more.

Otezla significantly improved measures of disease severity in adults with mild-to-moderate plaque psoriasis – Amgen

Written by | 29 Apr 2021

Amgen announced Otezla (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) affected by the disease , according… read more.

Johnson & Johnson single-shot COVID-19 vaccine phase III data published in New England Journal of Medicine

Written by | 28 Apr 2021

Johnson & Johnson announced publication in the New England Journal of Medicine of primary data from the Phase III ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed… read more.

UK MHRA approves Vazkepa to reduce the risk of cardiovascular events – Amarin Corp

Written by | 27 Apr 2021

Amarin Corporation announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Great Britain Marketing Authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce… read more.

FDA announce that vaccinations with JNJ 78436735 for COVID-19 can restart – Johnson & Johnson

Written by | 26 Apr 2021

Johnson & Johnson announced that vaccinations with JNJ 78436735, the Company’s COVID-19 single-shot vaccine, will resume for all adults aged 18 years and older in the U.S., under… read more.

DCGI (India) approves Sputnik V COVID 19 vaccine for emergency use in India – Dr Reddy’s Laboratories

Written by | 25 Apr 2021

Dr. Reddy’s Laboratories Ltd. announced that it has received the permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted… read more.

FDA approves Xolair prefilled syringe for self-injection across all indications – Genentech + Novartis

Written by | 24 Apr 2021

Genentech, a member of the Roche Group announced that the FDA has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all… read more.

Genentech’s Evrysdi continues to improve motor function and survival in babies with Type 1 Spinal Muscular Atrophy

Written by | 23 Apr 2021

Genentech, announced new 2-year data from Part 2 of FIREFISH, a Phase II/III global study evaluating Evrysdi (risdiplam) in infants aged 1-7 months at enrollment with symptomatic Type… read more.

FDA grants accelerated approval to Trodelvy for the treatment of metastatic urothelial cancer – Gilead Sciences

Written by | 22 Apr 2021

Gilead Sciences, Inc. announced that the FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC)… read more.

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