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A commonly used asthma medication, AstraZeneca’s Pulmicort (budesonide), was found to significantly reduce COVID-19 symptoms if given within seven days of symptoms appearing, UK researchers reported. Read More
A 10-member FDA advisory committee voted unanimously yesterday to defer a decision to recommend Merck’s blockbuster oncology drug Keytruda (pembrolizumab) for a new breast cancer indication and to await more data from a late stage trial. Read More
A strategy President Joe Biden outlined on the campaign trail to deal with U.S. supply chain vulnerabilities for critical products, including pandemic-related supplies, is likely to be put into effect via executive order within weeks. Read More
The FDA has approved Bristol Myers Squibb’s CAR T cell therapy Breyanzi for treatment of adults with relapsed or refractory large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. Read More
More than 100 nongovernmental organizations (NGOs) have urged the World Trade Organization (WTO) to extend a waiver of intellectual property rights to help developing nations access COVID-19 treatments and vaccines during the pandemic. Read More
The FDA is unlikely to help Merck’s chances of getting a positive recommendation from the agency’s Oncology Drugs Advisory Committee today for its blockbuster drug Keytruda (pembrolizumab) for a new indication. Read More
Pfizer said it can cut the time it takes to manufacture its COVID-19 vaccine by almost half from 110 days to an estimated 60 days, a change that should significantly increase the speed of U.S. vaccinations. Read More
Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference. Read More