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Appco Pharma’s Piscataway, N.J. generic drug manufacturing facility was dinged by the FDA for lacking temperature and humidity records for some equipment and other documentation lapses listed in a five-observation Form 483 following an Aug. 8-19 inspection. Read More
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28. Read More
The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutations, maintaining approval for the drug’s first-line indication. Read More
The Federal Trade Commission (FTC) has filed an amicus brief in the U.S. District Court for the District of Delaware arguing that some branded drug manufacturers have a history of using restricted distribution programs to delay the introduction of generic drugs. Read More
The FDA is seeking public comment on an International Council for Harmonisation (ICH) draft guidance that describes risk-based principles and mitigation strategies to assure viral safety in biotechnology products from cell lines. Read More
EQRx Therapeutics is dropping its U.S. developmental efforts for sugemalimab plus chemotherapy, a combination it was working on as a treatment for stage IV nonsmall cell lung cancer (NSCLC). Read More
BrainStorm Cell Therapeutics received an FDA refusal to file letter for NurOwn — the FDA’s third negative reaction to the investigational treatment — an autologous stem cell therapy aimed at promoting new nerve growth in patients with amyotrophic lateral sclerosis (ALS). Read More