Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
My View
Tags:
BioPharmaceutical Regulation

Keeping Track: KemPharm Apadaz Delay; Cholera Vaccine Approved

  • Analysis

Executive Summary

The latest drug development news and highlights from our FDA Performance Tracker. Vaxchora cholera vaccine is CBER's fourth novel biologic cleared this year; Adamis emergency Epi turned down again.

You may also be interested in...



Chikungunya Vaccine Development May Rely On Immunologic Biomarkers Instead Of Traditional Trials

As the mosquito-borne chikungunya virus spreads into temperate regions worldwide, US FDA convenes advisory committee for an open discussion on development of vaccines.

Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

Table

View full table

Related Content

Pink Sheet
Pink Sheet
Scrip
Pink Sheet
Pink Sheet

Topics

Related Companies

Tags:
BioPharmaceutical Regulation
Latest Headlines

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

Partisan Politics Returns To US FDA Congressional Oversight

GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows

Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development

See All
UsernamePublicRestriction

Register

PS057706

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By