FDA

All articles by FDA

BlueBird Bio’s 2-day reckoning is at hand
BlueBird Bio’s 2-day reckoning is at hand
Marc Iskowitz
June 9, 2022
9:36 am

Briefing documents suggest that one of two potential gene therapy launches may be in for a rough ride.

Five things for pharma marketers to know: Thursday, June 9, 2022
Five things for pharma marketers to know: Thursday, June 9, 2022
Larry Dobrow
June 9, 2022
5:00 am

More than 1,000 monkeypox cases worldwide; Vertex receives breakthrough designation for kidney drug; Biospring Partners closes its $245 million first fund.

Five things for pharma marketers to know: Monday, May 16, 2022
Five things for pharma marketers to know: Monday, May 16, 2022
Jack O'Brien
May 16, 2022
5:00 am

How many lives could have been saved with COVID vaccinations?; Baby formula shortage benefits Abbott stock; Novavax eyes FDA approval for COVID vaccine in June.

FDA turns down UCB application for psoriasis treatment
FDA turns down UCB application for psoriasis treatment
Jack O'Brien
May 13, 2022
10:19 am

UCB will review its full-year financial guidance in light of the agency’s decision.

FDA refutes Bourla’s advice on 2nd course of Paxlovid
FDA refutes Bourla’s advice on 2nd course of Paxlovid
Marc Iskowitz
May 6, 2022
4:11 pm

The CEO’s suggestion for dealing with patients whose COVID symptoms relapse — taking a second course of the antiviral pill — is not supported by data, the agency said.

Inside the FDA/McKinsey divorce
Inside the FDA/McKinsey divorce
Lecia Bushak
May 5, 2022
1:00 pm

The agency is severing ties with McKinsey in the wake of conflict-of-interest concerns around the consultancy’s work with opioid makers.

Bausch Health draws ‘untitled letter’ from OPDP for DTC video, HCP web page
Bausch Health draws ‘untitled letter’ from OPDP for DTC video, HCP web page
Marc Iskowitz
April 13, 2022
3:14 pm

It’s the second untitled letter of the year to point out the de-emphasis of risk information in drug promotion, as opposed to its omission.

Uncertainty lingers following FDA vaccine expert committee meeting
Uncertainty lingers following FDA vaccine expert committee meeting
Jack O'Brien
April 8, 2022
4:49 pm

Another booster? New vaccines? Experts weren’t sure how to read the tea leaves.

Debate over accelerated approval emerges in Congress
Debate over accelerated approval emerges in Congress
Lecia Bushak
March 18, 2022
4:37 pm

Support for limiting drugmakers’ use of the regulatory pathway, or facilitating it, is split along party lines.

MM+M Podcast 2.22.22: It’s Robert Califf’s FDA 2.0
MM+M Podcast 2.22.22: It’s Robert Califf’s FDA 2.0
Marc Iskowitz
February 22, 2022
12:20 pm

Peter Pitts, a former FDA associate commissioner, weighs in on Dr. Robert Califf’s nomination as the FDA’s chief.

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