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…
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…
Because Abraxis Bioscience, a subsidiary of Celgene, didn’t fix the problem of multiple media fill failures along the aseptic processing line at its biologics plant, the FDA hit the Phoenix,…
Addressing sponsors’ desires to evaluate multiple versions of cell and gene therapy candidates in a single early phase trial, the FDA has issued guidance that encourages separate Investigational Drug Applications…
ADC Therapeutics’ Cami (camidanlumab tesirine), an investigational antibody-drug conjugate, has hit the end of its quest to gain accelerated approval for adults with heavily pretreated Hodgkin lymphoma, but — if…
In an 8-5 split, the members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted yesterday against an emergency use authorization (EUA) for VERU-11 (sabizabulin) for treatment of COVID-19 at patients…
Members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee agreed 16-1 that the first-ever inhaled combination of two already-approved asthma drugs would benefit adults, but they declined to recommend it for…
The FDA’s efforts to improve premarket safety analytics and documentation were met with comments from several drugmakers expressing concerns about standardization and harmonization with other data systems. Source: Drug Industry…
Generic drug makers are responsible for providing sufficient information in their abbreviated new drug applications (ANDA) to show that the generic drug’s active ingredient is the same as that of…
Neurotech Pharmaceuticals has announced positive phase 3 topline results from two trials evaluating its NT-501 eye treatment for patients with macular telangiectasia type 2 (MacTel). Source: Drug Industry Daily