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FDA Performance Tracker

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Keeping Track: Amarin And Nektar Signal Delays, DBV Returns, And Provention Notches A BTD

The latest drug development news and highlights from our US FDA Performance Tracker.

Drug Review Complete Response Letters Regulation

Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Colorectal, Bladder Cancer Therapies Are Top Prospects For April US FDA Approvals

Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.

US FDA Performance Tracker Drug Approval Standards

Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Keeping Track: J&J Submits Ponesimod NDA For MS; US FDA Clears Epclusa For Pediatric HCV

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Keeping Track: A Good Week For Interstitial Lung Diseases; Opdivo+Yervoy Gains Liver Cancer Claim

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Keeping Track: US FDA Clears Sanofi’s Sarclisa; KemPharm Submits Novel ADHD Drug

The latest drug development news and highlights from the Pink Sheet FDA Performance Tracker.

US FDA Performance Tracker Approvals

Keeping Track: Two Novel Migraine Drugs Highlight Busy Week For US FDA Approvals

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals US FDA Performance Tracker

March Madness: Upcoming US FDA Decision Dates To Watch

A dozen applications for new drugs and significant new indications are on the US FDA’s calendar of goal dates, including breakthrough-designated applications from Bristol-Myers Squibb and Boehringer Ingelheim.

User Fees US FDA Performance Tracker

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Review
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