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Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring an isocitrate dehydrogenase-1 (IDH1) mutation. Read More
Endo International announced that it will purchase the biopharmaceutical company BioSpecifics Technologies for approximately $540 million giving the company complete control over two promising collagenase-based therapies. Read More
The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine. Read More
China’s state-owned pharmaceutical company Sinopharm is gearing up to manufacture 1 billion doses of its two potential coronavirus vaccines in 2021. Read More
Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected out next month. Read More
Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Read More
The Government Accountability Office (GAO) on Monday agreed to begin looking into allegations that the Trump administration exerted political pressure on the FDA and Centers for Disease Control and Prevention (CDC) to influence pandemic-related policies, following a request by three Democrat senators. Read More
Roche and AbbVie have won FDA approval of Venclexta (venetoclax) in combination with the chemotherapy drugs azacytidine, decitabine or low-dose cytarabine for the treatment of acute myeloid leukemia in adults aged 75 or older, or those unable to undergo intensive chemotherapy. Read More