BioWorld

Aug. 30, 2010

Genentech Caught off Guard, FDA Issues Refuse-to-File for T-DM1

The FDA sent a refuse-to-file letter to Genentech Inc., a member of the Roche Group, rejecting the company's application for accelerated approval of trastuzumab-DM1 (T-DM1) and catching investors and the company off guard. (BioWorld Today) Read More

Otonomy Lures New Investors with $38.5M Series B Financing

Senate to Hold Hearing on Funding for Stem Cells

FDA Oversteps its Bounds for Jazz Fibromyalgia Drug

Genzyme's ERT Rationing to End Soon; Sanofi Still Biting?

Corrections & Clarifications

Clinic Roundup

Stock Movers

Financings Roundup

Other News To Note

U.S. Patent Disclosures

Bench Press

Today's news in brief

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BioWorld MedTech

BioWorld MedTech briefs for Jan. 23, 2026.

Illustration of magnifying glass inspecting brain

Neurotrimin unveiled as marker in intellectual disability

BioWorld Science

Neurotrimin (NTM) is a member of the IgLON family, the disruption of which has been tied to emotional learning deficits and anxiety-like behavior in animal...

DNA mutations or genetic disorder concept art

Biallelic variants in COX18 identified as cause of Charcot-Marie-Tooth disease

BioWorld Science

Charcot-Marie-Tooth (CMT) disease is a group of clinically and genetically heterogeneous sensorimotor peripheral neuropathies. It is the most frequent inherited...

Illustration of human body surrounded by DNA, cell and drug icons

Cell/gene therapy sector now sustainable; China competition mounting

BioWorld

There was an upbeat message for cell and gene therapy companies in the 2026 industry update presented as the J.P. Morgan Healthcare Conference opened on Monday,...