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preterm birth

Abbott faces trial over claims that preterm infant formula caused dangerous disease

Reuters

Mon, 07/8/24 - 11:43 am

Study finds Pfizer's RSV vaccine not tied to higher risk of pre-term births

Reuters

Mon, 07/8/24 - 11:42 am

real world data

FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency

BioPharma Dive

Mon, 03/6/23 - 11:37 pm

Adcomm again votes to pull controversial pre-term birth drug from the market

Endpoints

Wed, 10/19/22 - 01:20 pm

FDA opens case to withdraw controversial drug for preterm births

BioPharma Dive

Mon, 10/17/22 - 11:20 pm

Covis' controversial Makena gets FDA hearing date in bid to stay on the market

Fierce Pharma

Wed, 06/15/22 - 07:16 pm

FDA lawyer digs in her heels as Makena accelerated approval withdrawal saga drags on

Endpoints

Wed, 04/20/22 - 10:54 am

Covis granted FDA hearing in latest twist over controversial premature-birth med Makena

Fierce Pharma

Fri, 08/20/21 - 12:25 pm

FDA seeks withdrawal of Makena, generics from market

RAPS.org

Mon, 10/5/20 - 11:51 pm

Amag Pharmaceuticals

postmarketing studies

FDA Ad Com thumbs down on full Makena approval

Seeking Alpha

Tue, 10/29/19 - 11:00 pm

Amag Pharmaceuticals

advisory panels

Aspen's drug to prevent preterm birth approved by FDA

Reuters

Thu, 09/12/19 - 11:17 pm

Aspen Pharmacare

Years after it was OK'd, AMAG's drug for preventing preterm births fails badly in long-awaited confirmatory trial

Endpoints

Fri, 03/8/19 - 09:44 am

Amag Pharmaceuticals

FDA advisers give gel a failing grade

StL Today, MO

Sat, 01/21/12 - 05:57 pm

Columbia Laboratories

Watson Pharmaceuticals