Ironwood Pharmaceuticals Announces FDA Approval of Revised LINZESS® (linaclotide) Label
Ironwood Pharmaceuticals, Inc. - Class A (IRWD)
Last ironwood pharmaceuticals, inc. - class a earnings: 2/13 07:00 am
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Source: Business Wire
BOSTON--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for LINZESS® (linaclotide) based on clinical safety data that has been generated thus far in pediatric studies. The updated label modifies the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age. The boxed warning and contraindication previously applied to all children less than 18 years of age and less than 6 years of age, respectively. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. LINZESS is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).“The warning on the LINZESS label at launch was primarily applied due to preclinical findings, and there was an absence of any clinical
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- INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Ironwood Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
- ONGOING INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Ironwood Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
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- 2/15/24 - Miss
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Sec Filings
- 4/25/24 - Form ARS
- 4/25/24 - Form DEFA14A
- 4/25/24 - Form DEF
- IRWD's page on the SEC website