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The FDA is willing to consider a range of clinical trial designs and various endpoints for new drugs or biologics intended to treat acute myeloid leukemia (AML), according to a new draft guidance. Read More
The FDA has finally put muscle behind its authority to fine flouters of the ClinicalTrials.gov reporting requirements, issuing a final guidance last week that confirms penalties of up to $10,000 per violation. Read More
The EU’s orphan drug regulations are not adequately supporting the development of medicines for rare diseases, according to a new report conducted on behalf of the European Commission. Read More
The FDA’s Oncologic Drugs Advisory Committee voted 8-2 yesterday in support of Mesoblast’s stem-cell treatment Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease in children. Read More
The House Select Subcommittee on the Coronavirus Crisis is questioning how vaccines are being chosen for accelerated development under the U.S. government’s Operation Warp Speed and calling for details on possible conflicts of interest among those who are making the choices. Read More
Fee-paying drug sponsors who submit investigational new drug (IND) applications to the FDA generally get high-quality responses and communications from the agency, according to an independent assessment by Lexington, Mass.-based Eastern Research Group. Read More
In a final guidance released yesterday, the FDA explains how and when drug sponsors should notify the agency about products that they plan to withdraw from the market or that will not be offered for sale. Read More
The World Health Organization (WHO) will need $100 billion to pay for COVID-19 vaccines but it has only received commitments for 10 percent of that amount, according to the organization’s Director General Tedros Adhanom Ghebreyesus. Read More
The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Read More
Bristol Myers Squibb and collaborator Pfizer prevailed in a patent ruling last week when a Delaware federal judge upheld two patents for their blockbuster blood thinner Eliquis (apixaban). Read More