FDA officials on Aug. 21 notified the firm that its Fort Washington, Pa., manufacturing plant is compliant with the agency’s GMP regulations for drugs.
McNeil Consumer Healthcarecan increase its OTC drug manufacturing capacity as FDA signs off on remediation of the Johnson & Johnson subsidiary’s headquarters facility that was closed under a consent decree.
In a statement to “The Tan Sheet,” J&J/McNeil said FDA officials on Aug. 21 notified the firm that the Fort...
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.
Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.
The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.
The Oncologic Drugs Advisory Committee said the benefit-risk of belantamab mafoditin for two second-line multiple myeloma indications is not favorable at the proposed dosages and raised concerns about applicability of trial results to US patients.
