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Covis Pharma

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Latest From Covis Pharma

In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ

A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.

Coronavirus COVID-19 FDA

US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena

With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.

Review Pathway Drug Review

OIG Accelerated Approval Report Spotlights Financial Costs Ahead Of Congressional Debate

First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.

FDA Clinical Trials

Regulatory Flexibility: US FDA Approves Amylyx’s Relyvrio For ALS Despite ‘Degree Of Residual Uncertainty’

The single positive Phase II CENTAUR study, along with confirmatory evidence of benefit on long-term survival in the open-label extension, demonstrate substantial evidence of effectiveness, the agency says, acknowledging a level of uncertainty that is acceptable in the disease context.

Approvals Drug Review
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