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Biologics

Agenus BLA for Cervical Cancer Therapy

Agenus files a BLA seeking accelerated approval for balstilimab, an anti-PD-1 antibody for treating patients with recurrent or metastatic cervical can...

Human Drugs

Clinical Hold on Ovarian Cancer Cell Therapy

FDA places a clinical hold on an Anixa Biosciences ovarian cancer chimeric antigen receptor-T cell therapy being developed in partnership with Moffitt...

Court Hits FDA Discretion in Drug/Device Decisions

The DC Circuit Court of Appeals affirms a lower court decision that FDA is not afforded discretion when a combination product meets the definition of ...

Human Drugs

FDA Overreacted on J&J Vaccine Pause: Ex-Official

Pacific Research Institute senior fellow and former FDA Office of Biotechnology director Henry I. Miller says FDAs decision to recommend a pause on Jo...

Medical Devices

Tenacore Recalls Alaris Pumps Over Bezel Posts

Tenacore recalls Alaris Pumps it serviced because bezel repair posts may crack or separate leading to inaccurate fluid delivery.

Biologics

J&J Vaccine Maker Halts Production

Emergent BioSolutions, contract Covid-19 vaccine supplier to Johnson & Johnson, agrees to not manufacture bulk drug substances and to quarantine exist...

Medical Devices

FDA Hits Block Scientific Over Covid Products

FDA sends Block Scientific a Warning Letter after reviewing its Web site and determining it is marketing Covid-19 test kits without agency approval, c...

Federal Register

Some Software Functions Exempted from Device Definition

Federal Register final rule: FDA amends certain medical device classification regulations to exclude certain software functions from the definition of...

Federal Register

Latex Gloves Need 510(k); More Surveillance

Federal Register notice: FDA clarifies that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon and patient examinati...

Human Drugs

Opdivo OKd for Gastric Cancer

FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients with advanced or met...