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REMS

FDA’s liver safety request set to delay decision on Travere’s kidney drug

Fierce Biotech

Sun, 10/16/22 - 05:12 pm

Travere Therapeutics

FDA proposes plan to mail back unused opioids

RAPS.org

Fri, 04/22/22 - 10:38 am

FDA removes in-person dispensing requirement for abortion medication

RAPS.org

Sat, 12/18/21 - 10:51 pm

FDA seeks comment on plan to increase REMS transparency

RAPS.org

Sat, 11/7/20 - 11:04 pm

Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing

Xconomy

Tue, 03/24/20 - 10:20 am

Aimmune Therapeutics

drug manufacturing

FDA Eliminates REMS for HIV Drug Truvada and its Generics

RAPS.org

Tue, 07/2/19 - 12:06 pm

Gilead Sciences

FDA reviewers: REMS could allay safety concerns for Sage's brexanolone

BioCentury

Wed, 10/31/18 - 06:47 pm

SAGE Therapeutics

postpartum depression

Drugmakers exploit REMS to restrict generics, and it doesn't bode well for biosimilars

Fierce Pharma

Tue, 03/8/16 - 10:21 am

A Bill Would Prevent Drug Makers From Frustrating Generic Rivals

WSJ Pharmalot

Tue, 06/23/15 - 10:40 am