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The US FDA’s Nifty Fifty

 
• By Michael McCaughan

FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?

50 celebration balloons and confetti (shutterstock_1663645954)
• Source: Shutterstock

When the US Food & Drug Administration approved MacroGenics, Inc.’s metastatic breast cancer treatment Margenza (margetuximab-cmkb) on December 16, it didn’t get a whole lot of attention.

FDA, of course, was in the news plenty already, thanks to the first COVID-19 vaccine authorization and the pending advisory...

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More from Approvals

US FDA Maintaining Approval Output Despite Losing Staff

 
• By Derrick Gingery

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

More from Product Reviews

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.