trending Market Intelligence /marketintelligence/en/news-insights/trending/pMpBqhcdY0uT2pNAgAAyzw2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Approvals for Merck & Co., Bayer; designations for Momenta, Nektar Therapeutics

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform

Approvals for Merck & Co., Bayer; designations for Momenta, Nektar Therapeutics

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 2.


* Merck & Co. Inc.'s Keytruda for squamous cell carcinoma of the esophagus that has spread to other parts, with the tumors expressing the PD-L1 protein, as determined by an FDA-approved test.

* Bayer AG and Orion Oyj's Nubeqa for castration-resistant prostate cancer that has not spread to other parts of the body.

* Agilent Technologies Inc.'s PD-L1 IHC 22C3 pharmDx diagnostic test to identify patients with esophageal squamous cell carcinoma who are eligible for treatment with Merck & Co. Inc.'s Keytruda.

* Zeus Scientific Inc.'s Zeus Elisa enzyme immunoassay tests to diagnose Lyme disease.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: Associated Press

Fast track

* Momenta Pharmaceuticals Inc.'s M281 for hemolytic disease of the fetus and newborn.

Breakthrough therapy

* Nektar Therapeutics' NKTR-214 in combination with Bristol-Myers Squibb Co.'s Opdivo for previously untreated skin cancer that cannot be removed completely through surgery or has spread to other parts of the body.

Other designations

* Orphan drug, for Genfit SA's elafibranor for primary biliary cholangitis.

* Orphan drug, for Neuren Pharmaceuticals Ltd.'s NNZ-2591 for Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.

* Regenerative medicine, for Orchard Therapeutics PLC's gene therapy OTL-103 for Wiskott-Aldrich syndrome.