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Device for treating challenging bone fractures cleared by FDA

Written by | 26 Jul 2023

A new system for fixing bone fractures, called the Bone Bolt System, has been approved for market by the U.S. Food and Drug Administration (FDA), the University of… read more.

FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome – Ipsen

Written by | 24 Jun 2023

Ipsen announced that the FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). Bylvay is… read more.

FDA approves Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Written by | 22 Jun 2023

Roche announced that the FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified… read more.

FDA approval for Inpefa to treat heart failure – Lexicon Pharma

Written by | 3 Jun 2023

Lexicon Pharmaceuticals, Inc. announced that the FDA has approved Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent… read more.

A sharp increase in the price of the gout drug colchicine led to lower use and poorer disease control, UCLA research suggests

Written by | 11 May 2023

Due to a policy decision in 2010 by the U.S. Food and Drug Administration (FDA), the price of a prescription for the therapeutic gout drug colchicine increased nearly… read more.

Artificial pancreas improves blood sugar control in young children with type 1 diabetes

Written by | 21 Mar 2023

An artificial pancreas improves blood sugar control in children ages 2 to 6 with type 1 diabetes, researchers reported on March 16, 2023 the NEJM/New England Journal of Medicine…. read more.

A drug that treats alcoholism may be the next anti-anxiety medication

Written by | 16 Apr 2022

Alcoholism, if left untreated, could have dangerous repercussions. Thus, it is no surprise that there are a range of drugs developed to treat this condition. Of these drugs,… read more.

Pfizer and BioNTech receive first FDA Emergency Use Authorization of a COVID-19 vaccine booster

Written by | 20 Oct 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age… read more.

FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Written by | 17 Oct 2021

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized… read more.

FDA approves Keytruda to treat high-risk early-stage triple-negative breast cancer – Merck Inc.

Written by | 9 Aug 2021

Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy… read more.

FDA accepts Alymsys filing for metastatic colorectal cancer – Amneal Pharma

Written by | 27 Jun 2021

Amneal Pharmaceuticals announced the FDA has accepted for review the Biologics License Application (BLA) for bevacizumab biosimilar for the treatment of metastatic colorectal cancer, in combination with intravenous… read more.

FDA grants accelerated approval for Aduhelm to treat Alzheimer’s disease – Biogen + Eisai

Written by | 15 Jun 2021

Biogen and Eisai, Co., Ltd. announced that the FDA has granted accelerated approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’sdisease treatment to address a defining pathology… read more.

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