FDA Generic Epinephrine Guidance - AI-Generated

New FDA Guidance Could Open Door to More Generic Epinephrine Options

Dave Bloom - 2026/09/01 0

The FDA issued draft guidance for generic epinephrine, potentially improving competition, access, and affordability.

State Bill is a Model for the Country: $0 Out-of-Pocket for Epinephrine, Insulin, and...

Dave Bloom - 2026/06/16 0

“If you pay for insurance, you should never be forced to ration your medication just to breathe, manage diabetes, or survive a severe allergic reaction."

The neffy® Mega FAQ: Everything to Know About the World’s First Needle-Free Emergency Epinephrine...

Dave Bloom - 2026/06/10 0

Everything you need to know about neffy, the first needle-free epinephrine alternative—from switching options to cost and convenience.

Delayed Epinephrine Drives Fatal Anaphylaxis in Children According to New Study

Dave Bloom - 2026/04/28 0

Delayed or missing epinephrine is common in fatal pediatric anaphylaxis, with cardiac arrest often occurring within minutes.

Canada Approves neffy®, the First Needle-Free Emergency Epinephrine Treatment

Dave Bloom - 2026/04/16 0

Health Canada approves needle-free neffy nasal spray, offering a new epinephrine option for Canadians with severe allergies.

Aquestive's Anaphylm Emergency Epinephrine Sublingual Film

Sublingual Epinephrine Advances as FDA Clarifies Requirements for Approval

Dave Bloom - 2026/03/31 0

FDA feedback clarifies next steps for Anaphylm, an investigational oral epinephrine film, as Aquestive targets NDA resubmission later this year.

FDA Removes Age Restriction for neffy® Nasal Epinephrine, Expanding Access for Young Children

Dave Bloom - 2026/03/27 0

FDA removes age restriction for neffy, allowing younger children over 33 pounds access to needle-free epinephrine for emergency allergy treatment.

Partnership Will Onshore Manufacturing to Stabilize and Secure US Epinephrine Supply

Dave Bloom - 2026/03/18 0

Fresenius Kabi and Phlow Corp have announced a major collaboration to onshore the complete manufacturing process of Epinephrine Injection, USP. The partnership aims to...

England Works to Mandate Epinephrine in Every School While Survival in the US Depends...

Dave Bloom - 2026/02/03 0

In the US, a child’s safety from anaphylaxis at school depends entirely on the state or municipality they live in.

FDA Delays Approval of Aquestive’s Anaphylm™ Sublingual Epinephrine Film

Dave Bloom - 2026/02/02 0

The primary deficiencies cited by the FDA involve human factors (HF) validation and administration, such as packaging, not the drug itself.

epinephrine auto-injector - search results