Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption

Jan 30 2019

• By Bridget Silverman

"Uncertainty Ahead” sign on a background of blue sky with clouds

Related Content

US FDA’s Best Year Ever For New Drugs: CDER Novel Approvals Hit 59

Jan 01 2019

CDER's Novel Approvals In 2018 Show Remarkable Review Consistency

Jan 25 2019

US FDA’s REMS Reluctance On Display At Recent Advisory Committees

Jan 25 2019

Keeping Track: FDA's Review Actions Carry On During Shutdown

Jan 20 2019

Sage's Brexanolone Could Be Transformative, But Only In Controlled Settings, US FDA Panel Says

Nov 02 2018

Can US FDA's Talk Therapy Cure What Ails Mental Health R&D?

May 31 2018

Alkermes' Depression Drug Likely Needs Another Trial After Crushing US Advisory Cmte. Vote

Nov 02 2018

Merck KGaA Foresees Mid-2019 US Launch Of Oral MS Therapy Mavenclad

Oct 16 2018

US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals

Jan 21 2019

Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

Jan 18 2019

Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

Jan 17 2019

2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections

Jan 09 2019

Drug Safety Announcement Blitz Highlights Gottlieb's PR Savvy As Shutdown Drags On

Jan 10 2019

Shutdown Deal Avoids Further US FDA Service Cuts, But Damage May Linger

Jan 26 2019

Keeping Track: Bad News For Bristol And Lilly, Good News For TG Therapeutics

Jan 27 2019

Bristol Stuck In Waiting Game As Opdivo TMB Gamble Fails To Pay Off

Jan 25 2019

Related Companies

Immunomedics, Inc.

Alkermes plc

Amgen, Inc.

Sanofi

Lexicon Pharmaceuticals, Inc.

Sage Therapeutics, Inc.

Merck KGaA

Merck KGaA

Samsung Bioepis Co., Ltd.

Merck & Co., Inc.

Genentech, Inc.

Bristol Myers Squibb Company

Eli Lilly and Company

Roche Holding AG

Bristol Myers Squibb Company

Johnson & Johnson

Astex Pharmaceuticals, Inc.

Daiichi Sankyo Co., Ltd.

Karyopharm Therapeutics

Heron Therapeutics, Inc.

Novartis AG

Ivax Corp.

Biogen, Inc.

Nektar Therapeutics

Societal CDMO, Inc.

Dr. Reddy's Laboratories Ltd.

Neurelis, Inc.

Nualtis

Jazz Pharmaceuticals plc

Eisai Co., Ltd.

Purdue Pharma L.P.

Vanda Pharmaceuticals, Inc.

Harmony Biosciences Holdings, Inc.

Proteon Therapeutics, Inc

Additional Topics

United States Drug Review Approvals Regulation Pink Sheet Perspectives BioPharmaceutical

More from Product Reviews

More from Pink Sheet

Twitter feed RSS feed RSS feed

About UsOpens in new window
Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us
Customer Service
Subscribe
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window