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August 02, 2021
The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.
July 30, 2021
In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.
July 29, 2021
EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.
July 27, 2021
Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.
July 15, 2021
EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.
After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.
EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).
July 12, 2021
FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.
July 02, 2021
The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.
Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.