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US FDA's Record-Breaking Month Of Breakthrough Therapy Designations

 
• By Michael Cipriano

Alnylam's ALN-AS1 became the eighth announced therapy to receive a breakthrough designation in May 2017, breaking the previously monthly high of seven.

Alnylam Pharmaceuticals has capped off a busy month of breakthrough therapy recipients, with the company announcing the designation May 31 for its ALN-AS1 (givosiran) an RNAi treatment designed for the prevention of attacks in patients with acute hepatic porphyria.

A family of rare diseases, acute hepatic porphyrias can result in patients experiencing severe neurovisceral attacks that can lead to...

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PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
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Global Pharma Guidance Tracker - July 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

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• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.