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Updated drug information handout outdoes FDA’s version

Written by | 12 Feb 2025

A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an updated version developed by researchers at the University of… read more.

FDA clearance of the HYDROS Robotic System, the next-generation, AI-powered platform for aquablation therapy – PROCEPT BioRobotics Corporation

Written by | 1 Sep 2024

PROCEPT BioRobotics Corporation announced FDA 510(k) clearance of its next-generation platform, the HYDROS Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI treatment planning, advanced… read more.

US drug approvals 2010-2019 align with US, but not global, burden of disease; expedited approval programs may make the gap worse

Written by | 17 Mar 2024

Drug approvals in the United States between 2010-2019 were aligned with the US, but not global, burden of disease and the increasing number of expedited drug approvals could… read more.

FDA accepts BLA for Ustekinumab biosimilar – Alvotech

Written by | 21 Feb 2024

The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT 04) referencing Stelara, which will be used to treat several autoimmune disorders. Alvotech… read more.

New study points to supply chain disruptions if the FDA removes ineffective decongestant from the market

Written by | 10 Feb 2024

In a new study of nasal decongestant purchasing patterns, researchers at the University of Pittsburgh School of Medicine found that phenylephrine remained the most popular choice year after… read more.

Drug manufacturers use FDA, patent strategies to keep insulin prices high

Written by | 18 Nov 2023

Over the last four decades, insulin manufacturers have extended their periods of market exclusivity on brand-name insulin products by employing several strategies, including filing additional patents on their… read more.

Nearly half of oncology drugs approved since 1998 are precision therapies

Written by | 20 Oct 2023

Of the 198 new oncology drugs approved by the U.S. Food and Drug Administration (FDA) between 1998 and 2022, approximately 43% were precision oncology therapies, the use of… read more.

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.

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