Food and Drug Administration (FDA)
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The FDA issued new guidance urging drugmakers to submit racial and minority recruitment plans when designing their studies.
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
The FDA has sprung into action, cracking down on the illegal sales of Adderall, as well as on CBD companies making claims their products are effective treatments or cures for COVID-19.
Halozyme Therapeutics announced that it is acquiring Antares Pharma for $960 million in cash. The news caused Antares stock to rocket 47% in premarket trading.
The trial demonstrated a safety profile in the younger age group as seen in patients 12 and older, with no severe side effects and no one dropping out from adverse events.
The FDA’s decision to lift the hold directive on April 11 involving the investigational drug magrolimab follows a comprehensive review of each trial’s safety data.
As Aeglea presents the data this week at the Society for Inherited Metabolic Disorders (SIMD), its stock has responded to both announcements with a strong leap.
Curis, a biotech company that develops treatments for cancer, has announced that the FDA has placed a partial clinical hold on its TakeAim lymphoma study.
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