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FDA issues a complete response letter for Akebias vadadustat citing a negative benefit/risk assessment and safety concerns.[ Price : $8.95]
FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes 6 to 4 that data from a single randomized, controlled tr...[ Price : $8.95]
FDA warns Salinas, Puerto Rico-based Agropharma Laboratories about repeat CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA authorizes a second booster dose of the Pfizer and Moderna Covid-19 vaccines for older adults and some immunocompromised peopl...[ Price : $8.95]
FDA warns Mazowieckie, Poland-based Dr Retter Ec Wladyslaw Retter about CGMP violations in its production of over-the-counter drug...[ Price : $8.95]
Three stakeholders submit general and specific comments on an FDA computational modeling and simulation draft guidance.[ Price : $8.95]
FDA approves ViiV Healthcares Cabenuva (cabotegravir, rilpivirine) for treating HIV-1 in certain virologically suppressed adolesce...[ Price : $8.95]
FDA clears a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in ...