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Mesothelioma Immunotherapy Vaccine Receives Orphan Drug Designation From FDA, Baron & Budd Reports

2015-04-29 04:58:10| drugdiscoveryonline Home Page

The mesothelioma law firm of Baron & Budd reports the U.S

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PharmaEngine Announces Merrimack Completed MM-398 (PEP02) New Drug Application Submission To U.S. FDA

2015-04-29 03:56:16| drugdiscoveryonline Home Page

PharmaEngine, Inc. recently announced that its licensing partner, Merrimack Pharmaceuticals, Inc. has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection) to the U.S

Tags: us application completed drug

 
 

Lilly's CYRAMZA (ramucirumab) Receives Fourth FDA Approval

2015-04-27 05:33:40| drugdiscoveryonline Home Page

Eli Lilly and Company (NYSE: LLY) has received its fourth U.S. Food and Drug Administration (FDA) approval for CYRAMZA® (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

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FDA records: 5th death associated with Essure

2015-04-25 23:22:55| Real Estate - Topix.net

Opponents of a controversial development in Carmel Valley collected enough referendum petition signatures to force the San Diego City Council to either rescind its approval of the project or put the issue to voters, the City Clerk's Office announced Friday. More than 60,000 signatures were turned in by opponents of the 23.6-acre project, far more than the 34,000-plus needed to qualify.

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New FDA Draft Guidance: eCTD Is Coming to Promotional SubmissionsAre You Ready?

2015-04-23 16:57:36| drugdiscoveryonline Home Page

Date: Friday, May 15, 2015 Time:1pm - 2:30pm EDT Duration: 90 Minutes - Online $299 - Introductory Rate

Tags: you coming ready draft

 

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