We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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The FDA is seeking public comment on an International Council for Harmonisation (ICH) draft guidance that describes risk-based principles and mitigation strategies to assure viral safety in biotechnology products from cell lines.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
The FDA offers detailed information on the regulatory flexibilities it offers to drugmakers that have products in expedited programs to help them overcome chemistry, manufacturing and controls (CMC) in a Manual of Policies and Procedures (MAPP) released yesterday. Read More