Logo

FDA

Seagen Going After Tukysa, Herceptin Combo Approval in HER2-Positive Colorectal Cancer

The company plans to seek accelerated approval for the regimen after seeing a 38 percent objective response rate in the MOUNTAINEER trial.

FDA, Industry Look to Congress to Reauthorize User-Fee Act, Improve Cell Therapy Regulation
Premium

The agency acknowledges its staff can't keep up with the volume of cell and gene therapy products and is looking to PDUFA VII for additional funds. 

FDA Asks Industry to Come Up With Plans to Address Diversity in Drug, Diagnostic Trials
Premium

It remains to be seen how precision oncology drug and genetic test developers will improve representation of racial and ethnic minorities based on the agency's guidelines.

In Brief This Week: Achilles Therapeutics, Zenith Epigenetics, Turning Point Therapeutics

News items for the week of May 8, 2022.

In Brief This Week: OncoHost, Matica Biotechnology, Xilis, Aptose Biosciences, Cigna

News items for the week of May 2, 2022.

Apr 25, 2022

Bill to Reform FDA Accelerated Approval Process May Stymie Precision Oncology Progress, Experts Say
Premium

Apr 21, 2022

Consensus Builds for Real-World Evidence to Support Multi-Cancer Screening Tests
Premium

Apr 13, 2022

FDA Lifts Partial Clinical Holds for Some Gilead Trials

Apr 13, 2022

RACE for Children Act Spurs Pharma to Study Molecularly Informed Drugs in Pediatric Cancer Patients
Premium

Apr 13, 2022

Turning Point Therapeutics' NDA Submission for Repotrectinib in Sight Based on Registrational Data

Apr 12, 2022

Blue Earth Therapeutics to Begin Phase I/II Trial of Targeted Radiopharmaceutical for mCRPC

Apr 11, 2022

NewStem Files FDA De Novo Submission, Gets CE Mark for Stem Cell Mutational Analysis Software

Apr 8, 2022

In Brief This Week: Precigen, OncoHost, Artios Pharma, Qiagen, Ultivue, Paige, Oncimmune

Apr 6, 2022

Iovance Biotherapeutics Receives Positive FDA Feedback Supporting Lifileucel BLA Submission

Apr 4, 2022

European Commission Approves Immunocore's T-Cell Receptor Therapy Kimmtrak in Uveal Melanoma

Apr 1, 2022

In Brief This Week: Taiho Oncology, PamGene, Mursla, Autolus Therapeutics, Clovis Oncology

Mar 31, 2022

Pluvicto's Arrival in Prostate Cancer Brings Competition, Debate Over Imaging Agents
Premium

Mar 29, 2022

Novartis, Lantheus Partner on PSMA Imaging-Based Patient Selection in Pluvicto Trials

Mar 25, 2022

EMA's CHMP Issues Positive Recommendations for Novartis' Kymriah, Janssen's Carvykti

Mar 23, 2022

FDA Approves Novartis Radiologand Pluvicto for PSMA-Positive mCRPC With Imaging CDx

Mar 22, 2022

FDA Approves Merck's Keytruda for MSI-H, dMMR Endometrial Cancer With Roche CDx

Mar 18, 2022

In Brief This Week: Ideaya Biosciences, Pfizer, Strata Oncology, Qualigen Therapeutics

Mar 16, 2022

Iovance Biotherapeutics to Begin Clinical Trials of Gene-Edited TIL Therapy in Melanoma, NSCLC

Mar 11, 2022

FDA Approves Lynparza as Adjuvant Therapy With Myriad Genetics CDx for BRCA-Mutated Breast Cancer

Mar 2, 2022

RedCloud Bio to Begin Trial of Fourth-Generation EGFR Inhibitor in NSCLC Subgroup