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Califf Says Opioid Labeling Changes, Withdrawals Still Possible

 
• By Derrick Gingery

The US FDA commissioner also suggests the pain medications along with marijuana products should be regulated differently than other drugs.

Opioid bottles
FDA Commissioner Robert Califf said provider education still needs work to get prescribing under control. • Source: Alamy

Changing labels and potentially pulling the products from the market remain possibilities in the US Food and Drug Administration’s ongoing fight against opioid misuse and abuse.

FDA commissioner Robert Califf added during the 31 March Stat Breakthrough Science Summit that the agency is “looking carefully at...

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Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

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PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

More from Pink Sheet

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

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Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
• By Francesca Bruce

Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.