1. Pink Sheet
  2. >>Product Reviews
  3. >>Approvals

US FDA’s Fastest Approvals Concentrate In Oncology, Infectious Disease

 
• By Bridget Silverman

The agency’s quickest approvals include two in 2020 – Gilead’s Veklury and Seattle Genetics’ Tukysa – but two 1990s AIDS drugs are at the top of the list.

train fast run on railway track in sunny day

The recent, and quite rapid, approval of Gilead Sciences, Inc.’s Veklury (remdesivir) highlights the agency’s willingness to prioritize therapies for emerging infectious disease threats.

Veklury cleared the agency on 22 October 2020, just 77 days after NDA submission for treatment of COVID-19 requiring hospitalization....

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 Approvals

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

More from Product Reviews

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.