Allogene Therapeutics is halting the clinical trial for the company’s AlloCAR T cancer therapy after finding some chromosomal abnormality in a patient.
Pfizer Inc. and BioNTech SE asked U.S. regulators to authorize emergency use of their Covid-19 vaccine for children ages 5 to 11, a group for whom no shot is allowed, Pfizer said on Oct. 7.
Gemini Therapeutics announced Oct. 5 that the company is reducing employee headcount by 20 percent and ceasing some research and non-clinical programs as part of a corporate restructuring effort to focus on a clinical trial for geographic atrophy.
The U.S. Food and Drug Administration did not approve Polarean Imaging’s application for a new drug-device combination product, sending the company’s shares tumbling 60 percent.
The U.S. Food and Drug Administration accepted for filing the New Drug Application submitted by Acer Therapeutics Inc. and the company’s collaboration partner Relief Therapeutics Holding SA for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders.
Johnson & Johnson submitted data to the U.S. Food and Drug Administration for emergency use authorization of a booster shot of the company’s Covid-19 vaccine in people aged 18 and older.
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
AstraZeneca’s candidate breast cancer therapy Enhertu received a fourth Breakthrough Therapy Designation from the U.S. Food and Drug Administration after the health regulator issued another BTD based on a Phase III trial presented at the European Society for Medical Oncology Congress 2021.
Teva Pharmaceutical Industries temporarily halted drug production at the company’s Irvine plant in California to address issues raised by the U.S. Food and Drug Administration after a recent inspection, the company said on Oct. 4.
Mirum Pharmaceuticals Inc. said on Sept. 29 the company’s drug became the first U.S. approved therapy for treating itching in patients with a rare liver disorder called Alagille syndrome (ALGS).
