Choice Of Regulatory Pathway Is Key Inflection Point In Drug Reviews
A year of Drug Review Profiles in the Pink Sheet shows how important the choice of regulatory pathway has become to drug development and approval.
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Antibiotic Incentives Helped Spero Get Where It Is Today
The firm is developing a novel class of antibacterials that could enable shelved agents for Gram-positive infections to reach and kill Gram-negative bacteria.
Patient Voices Swayed FDA's Imlygic Review Team
Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.
Chin Fat Not A 'Serious Condition' Worthy Of Priority Review, FDA Says
Deoxycholic acid offers safe and effective alternative to 'unapproved and unregulated' pharmacy compounded products, Kythera asserted in unsuccessful bid for shorter review.