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:
US FDA Performance Tracker Complete Response Letters Drug Approval Standards

Keeping Track: US FDA Approves Amgen’s Lumakras, Myovant’s Myfembree; New Claims For Biohaven’s Nurtec, BMS’ Zeposia

  • News

Executive Summary

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

You may also be interested in...



Accord Sees Two Hybrids Endorsed By EU’s CHMP

The latest CHMP meeting has seen the EMA committee issue a positive opinion on two Accord hybrid medicines, Zolsketil (doxorubicin) and Camcevi (leuprorelin), at the same time as SERB’s generic amifampridine tablets were also endorsed.

Keeping Track: Orphan Drugs Aplenty At US FDA, From Pyrukynd Approval To Adagrasib Standard Review

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

Amgen Strikes Early-Access Deal In England For Lung Cancer Drug Lumakras

Patients in England with non-small cell lung cancer will be the first In Europe to be offered Amgen’s KRAS G12C inhibitor.

Table

View full table

Related Content

Pink Sheet
Scrip
Scrip
Scrip
Scrip
Pink Sheet
Pink Sheet

Topics

Related Companies

Tags:
US FDA Performance Tracker Complete Response Letters Drug Approval Standards
Latest Headlines

WHO Seeks Feedback On Gaps In Current QA & GMP Guidelines

Republican Lawmaker Takes Unusual Step Of Attacking FDA Salaries Over Abortion Pill Decisions

FTC Merger Guidelines Cast ‘Perilous Shadow’ Over Biopharma

NurOwn Adcomm Is 20 Members Strong Despite US FDA’s ‘Struggle’ To Find Unconflicted Neurology Experts

See All
UsernamePublicRestriction

Register

PS144402

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