FDA Approval for VYALEV issued to ABBVIE INC

10/17/24 1:29:31 PM ET

$ABBV

Biotechnology: Pharmaceutical Preparations

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New Drug Application (NDA): 216962
Company: ABBVIE INC

Products on NDA 216962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYALEV	FOSCARBIDOPA AND FOSLEVODOPA	12MG/240MG / ML	INJECTION;SOLUTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf

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Recent Analyst Ratings for
$ABBV

Date	Price Target	Rating	Analyst
11/4/2024		Hold → Buy	Argus
10/17/2024	$203.00	Mkt Perform	Bernstein
6/5/2024	$185.00	Hold → Buy	HSBC Securities
5/17/2024	$200.00	Overweight	Cantor Fitzgerald
1/29/2024		Mkt Perform → Outperform	William Blair
12/18/2023		Buy → Hold	HSBC Securities
12/11/2023		Neutral → Buy	Goldman
11/9/2023	$150.00	Hold	Deutsche Bank

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AbbVie and EvolveImmune Therapeutics Announce Collaboration and Option-to-License Agreement to Develop Next-Generation Cancer Biotherapeutics
NORTH CHICAGO, Ill. and BRANFORD, Conn., Oct. 31, 2024 (GLOBE NEWSWIRE) -- AbbVie (NYSE:ABBV) and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, today announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. EvolveImmune's proprietary EVOLVE platform is designed to deliver potent, selective and integrated T-cell co-stimul
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AbbVie to Host Third-Quarter 2024 Earnings Conference Call
NORTH CHICAGO, Ill., Oct. 1, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) will announce its third-quarter 2024 financial results on Wednesday, October 30, 2024, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas
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Allergan Aesthetics Celebrates the Second Annual JUVÉDERM® Day
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7/10/24 8:00:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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FDA Approval for VYALEV issued to ABBVIE INC

Products on NDA 216962

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216962

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $ABBV

$ABBV Press Releases

Fastest customizable press release news feed in the world

AbbVie and EvolveImmune Therapeutics Announce Collaboration and Option-to-License Agreement to Develop Next-Generation Cancer Biotherapeutics

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