1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

Keeping Track Of Submissions: Myovant’s First Relugolix NDA; Merck Resubmits Longer Keytruda Dosing; Biogen Adjusts Aducanumab Rolling Target

 
• By Bridget Silverman

The latest news and highlights about submissions for US approval, from the Pink Sheet FDA Performance Tracker.

Submissions continue to arrive at the US Food and Drug Administration despite the restrictions and challenges posed by COVID-19, led by a new molecular entity from Myovant Sciences Ltd.. Novel biologics from Biogen Inc. and Provention Bio Inc. continue to move forward with rolling submissions, although Biogen extended the timeline for its high-profile Alzheimer’s therapy aducanumab.

FDA also started reviewing new and improved dosing regimens for Merck & Co. Inc.’s Keytruda (longer interval between doses), Genentech Inc.’s Ocrevus (shorter infusion time) and Biogen’s Plegridy...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.