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Onyx Pharmaceuticals, Inc.

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Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma

The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Prescription To OTC Switch Approvals

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, other Rx 4-mg nasal sprays, available through abbreviated NDAs as generics of Narcan, must transition to OTC, FDA says.

FDA Approvals

Cross-Border M&A: 10 Key Trends To Watch In 2023

It will come as no surprise that cross-border M&A is impacted by the world we live in, with geopolitical tensions, rising inflation and interest rates, currency fluctuations, and increased regulatory scrutiny all playing their part in making deals more challenging to execute.

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