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

BioWorld

BioWorld briefs for July 24, 2026.

4D Nucleome opens new wave of gene regulation research, discovery

BioWorld

After a decade of research, the NIH 4D Nucleome program on July 23 delivered a wealth of new insights into how spatial changes in chromatin structure and DNA...

Other news to note for July 22, 2026

BioWorld

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Akari, Ashlins, Azurity, Eli Lilly, Engitix, Forge Biologics,...

In the clinic for July 21, 2026

BioWorld

Clinical updates for biopharma and med tech, including data readouts and publications: 4D, Actinogen, Belite, Harrow, Nuvation, Prolocor, Regenxbio, Samsung Bioepis.

GSK’s newly acquired Jideytro wins FDA nod in NSCLC

BioWorld

About a week after closing its $10.6 billion acquisition of Nuvalent Inc., GSK plc has reaped the first reward, announcing U.S. FDA approval of zidesamtinib in...