Makena

FDA forces unproven premature birth drug Makena off market
The Hill
Thu, 04/6/23 - 11:40 am
Makena
premature birth
Covis Pharma
FDA
FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency
BioPharma Dive
Mon, 03/6/23 - 11:37 pm
FDA
Makena
preterm birth
Covis Pharma
Adcomm again votes to pull controversial pre-term birth drug from the market
Endpoints
Wed, 10/19/22 - 01:20 pm
FDA
Covis Pharma
Makena
preterm birth
FDA opens case to withdraw controversial drug for preterm births
BioPharma Dive
Mon, 10/17/22 - 11:20 pm
FDA
Makena
Covis Pharma
preterm birth
CDER proposes withdrawal of approval for Makena
FDA
Sun, 10/9/22 - 05:58 pm
FDA
CDER
Makena
pre-term birth
Covis' controversial Makena gets FDA hearing date in bid to stay on the market
Fierce Pharma
Wed, 06/15/22 - 07:16 pm
Makena
Covis Pharma
FDA
preterm birth
FDA lawyer digs in her heels as Makena accelerated approval withdrawal saga drags on
Endpoints
Wed, 04/20/22 - 10:54 am
Covis Pharma
Makena
FDA
preterm birth
Premature birth drug saga drags on as Covis questions fairness of FDA hearing
Endpoints
Wed, 02/9/22 - 10:17 am
Makena
Covis Pharma
FDA
premature birth
Covis granted FDA hearing in latest twist over controversial premature-birth med Makena
Fierce Pharma
Fri, 08/20/21 - 12:25 pm
Covis Pharma
Makena
preterm birth
FDA
FDA puts its foot down on Makena: New meta-analysis does not change call to pull the drug
Endpoints
Mon, 03/29/21 - 10:39 am
Makena
FDA
premature birth
Covis Pharma
FDA seeks withdrawal of Makena, generics from market
RAPS.org
Mon, 10/5/20 - 11:51 pm
Amag Pharmaceuticals
Makena
FDA
preterm birth
postmarketing studies
AMAG CMO hits the exit just as biotech searches for new CEO to right a ship rocked by Makena controversy
Endpoints
Wed, 03/4/20 - 10:46 am
Amag Pharmaceuticals
Makena
Call for FDA to withdraw preterm birth drug divides doctors and insurers
Fierce Pharma
Mon, 01/27/20 - 10:47 am
pre-term birth
Makena
physicians
insurers
FDA
Amag Pharmaceuticals
Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals
RAPS.org
Fri, 11/1/19 - 06:52 pm
Makena
FDA
preterm labor
accelerated approvals
FDA Ad Com thumbs down on full Makena approval
Seeking Alpha
Tue, 10/29/19 - 11:00 pm
Makena
preterm birth
Amag Pharmaceuticals
FDA
advisory panels
Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
Stat
Tue, 10/8/19 - 09:20 am
Makena
premature birth
Amag Pharmaceuticals
FDA
citizen petitions
Public Citizen
FDA review of troubled drug could hobble AMAG in proxy fight with activist investor
Fierce Pharma
Thu, 09/26/19 - 07:43 pm
Amag Pharmaceuticals
shareholders
FDA
Makena
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
Makena
preterm birth
FDA
KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style
FDA Law Blog
Tue, 07/8/14 - 10:18 am
Makena
KV Pharmaceutical
FDA
KV gets a second shot at forcing the FDA to restrict compounders on Makena
Fierce Pharma
Fri, 01/10/14 - 06:53 pm
Makena
KV Pharmaceutical
FDA

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