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Repeated problems with aseptic areas landed India’s global pharmaceutical company Cipla Limited a Form 483, in addition to new quality and computer control issues. Read More
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More
Biogen’s investigational drug for SOD1 amyotrophic lateral sclerosis (ALS), tofersen, has delivered more promising results in an extension study published in the New England Journal of Medicine. Read More
Paxlovid is currently FDA-authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee agreed yesterday — somewhat grudgingly — that Rebyota (RBX2660), Rebiotix’s standardized fecal microbiota suspension, is a safe and effective treatment for recurrent Clostridium difficile infections (CDI). Read More
Scottsdale, Ariz.-based BioLab Sciences has received an FDA warning letter for selling human tissue products without approved Biologics License Applications and for persistent deviations from current good manufacturing practice (cGMP) practices. Read More
In another move to address the opioid crisis, the FDA has issued a guidance — effective immediately — that clarifies some supply chain requirements for the overdose treatment Naloxone (naloxone hydrochloride) to help make the treatment more accessible. Read More
Spectrum Pharmaceutical’s experimental cancer drug Pozenveo (poziotinib) got the thumbs down from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in a vote of nine to four yesterday. Read More