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’s latest quarterly snapshot of the agency’s GDUFA II performance shows fewer abbreviated new drug applications (ANDAs) under review than for the same time last year and that the agency is taking much longer to issue tentative approvals. Read More
Syndax Pharmaceuticals announced that its targeted cancer therapy, SNDX-5613, induced complete remission for certain advanced leukemia patients in an early-stage study. Read More
Vertex Pharmaceuticals has paid $900 million to CRISPR Therapeutics, a Swiss-American biotech, to amend their collaborative agreement, entitling Vertex to more than half of the profits from future sales of CTX001, their investigational gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). Read More
Public Citizen is urging the FDA to convene an expert panel to discuss rescinding approval for Gilead Sciences’ Veklury (remdesivir) as a COVID-19 treatment. Read More
As global criminals step up efforts to exploit the pandemic, Pfizer is combating the sale of counterfeit versions of its COVID-19 vaccines in Mexico and Poland. Read More
FDA investigators observed multiple problems at Emergent BioSolutions’ beleaguered Bayview facility in an April 12 to April 20 inspection prompted by a manufacturing mix-up for Johnson & Johnson (J&J)’s and AstraZeneca (AZ)’s COVID-19 vaccines, making it unlikely that the plant will be authorized to produce J&J doses anytime soon. Read More
The FDA has granted priority reviews for two supplemental Biologics License Applications (sBLAs) by Seagen and Astellas Pharma for Padcev, their antibody-drug conjugate therapy for treating bladder cancer. Read More
The FDA has granted Breakthrough Therapy designation for Amgen’s investigational antibody bemarituzumab as a first-line treatment for gastric cancer. Read More
In a move that clears the way for EU member states to resume inoculations with the Johnson & Johnson (J&J) vaccine, the European Medicines Agency (EMA) concluded yesterday that the vaccine’s labeling should include a warning about the risk of blood clots and the company said vaccine deliveries in Europe will resume. Read More