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May 02, 2022
On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.
FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
April 27, 2022
Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.
April 26, 2022
Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.
April 25, 2022
FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.
Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.