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Bristol Myers Squibb (BMS) said it plans to withdraw Istodax’s indication as a monotherapy for peripheral T-cell lymphoma (PTCL) after at least one prior therapy. Read More
The Senate Appropriations Committee yesterday voted 25-5 to advance a proposed funding bill that would give the FDA a $200 million boost in nonuser-fee funding in fiscal 2022. Read More
The FDA has issued a warning letter to Syntec Pharma for failure to prevent cross-contamination and for other good manufacturing practice lapses at its drug facility in Farmingdale, N.Y. Read More
Mechanically ventilated patients with COVID-19 were 44 percent less likely to die when Olumiant (baricitinib) was added to the standard treatment regimen, according to a substudy of Eli Lilly’s COV-BARRIER trial. Read More
After a satisfactory review of toxicology data, the FDA has given Novartis the green light to test its spinal muscular atrophy (SMA) gene therapy, Zolgensma (AVXS-101), in patients aged two to 18 years. Read More
The FDA is working on new ways to monitor overseas drug manufacturing plants to alleviate the crippling inspection backlog it faces due to COVID-19 and is reaching outside the agency for a new pilot program. Read More
Sanofi plans to spend $3.2 billion to buy clinical-stage messenger-RNA (mRNA) therapeutics company Translate Bio, deepening its holdings in the mRNA space to develop new therapeutics and vaccines. Read More
The FDA yesterday issued a long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device. Read More