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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: 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

Keeping Track: Quick Trips From Breakthrough Designation To Market

Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.

US FDA Performance Tracker Drug Delivery

Keeping Track: Seqirus Pandemic Flu Vaccine Approved; Trevena Resubmits Oliceridine

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

US FDA Performance Tracker Drug Review

Keeping Track: Aimmune’s Peanut Allergen Approved; Novartis’ Inclisiran, Pfizer/Lilly’s Tanezumab, Bayer’s Nifurtimox Submitted

Highlights of the latest drug development news from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

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

US FDA Performance Tracker Approvals

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

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

US FDA Performance Tracker Drug Review

Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions

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

US FDA Performance Tracker Approvals

Keeping Track: Year-End Submissions Rush Brings Seven Novel Agents To US FDA

Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.

Drug Review Review Pathway

Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019

The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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