Following a successful appeal of a December 2025 CRL, the FDA concluded that Outlook Therapeutics' existing data provided substantial evidence, eliminating the need for new clinical trials.

Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026ISELIN, N.J., June 16, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on ...

ISELIN, N.J., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom ...

Patients with metastatic colorectal cancer that had stopped responding to at least two prior treatment regimens gained ...

Corey J. Langer, MD, FACP: Personally, I believe there’s still a role for bevacizumab in select patients despite the astounding survival advantages seen with KEYNOTE-189. There are patients who aren’t ...

The combination of atezolizumab plus bevacizumab could become a standard first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with high tumor mutation ...

There's a possible new standard of care on the horizon for unresectable hepatocellular carcinoma (HCC) after years of failed attempts to improve upon the outcomes of the current protocol — stand-alone ...

Flashback Foreword: Bevacizumab and FOLFOX4 for Colorectal Cancer and Bevacizumab Versus Placebo Plus Oxaliplatin-Based Chemotherapy in Metastatic Colorectal Cancer Patients with MCRC were randomly ...

Pervasive "unsustainable" clinical practices amid cat-and-mouse game with funding availabi ...

Alymsys from Amneal Pharmaceuticals and mAbxience is the third biosimilar referencing Avastin approved in the United States and the second of 3 biosimilar approvals Amneal expects in 2022. The FDA has ...

The current medical environment demands that quality health care is delivered at an affordable cost through the use of objective, unbiased clinical data. This study was undertaken to review the ...