regulatory

News

Novo Nordisk closes on EU okay for haemophilia antibody

Novo Nordisk's anti-TFPI antibody concizumab has been backed for approval in the EU as a once-daily drug to prevent bleeding episodes in people with haemophilia.

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Australia joins EU in turning down Alzheimer's drug Leqembi

Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks.

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FDA set to decide on GSK's gepotidacin antibiotic in March

The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in over 20 yea

Market Access

Medical start-ups must address the evolving risks of the FDA...

Embarking on the journey of a medical start-up is like navigating a complex labyrinth, where the final prize is the coveted FDA approval.

Market Access

Inflation Reduction Act proves positive boost for biosimilar...

For the pharma industry, the IRA has made headlines due to it allowing price negotiations on top-selling treatments.

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FDA knocks back Zealand's dasiglucagon once again

Zealand Pharma has suffered another setback in its bid to bring glucagon receptor agonist dasiglucagon for ultra-rare disease congenital hyperinsulinism (CHI) to the US market.

Novo Nordisk closes on EU okay for haemophilia antibody

Australia joins EU in turning down Alzheimer's drug Leqembi

FDA set to decide on GSK's gepotidacin antibiotic in March

Medical start-ups must address the evolving risks of the FDA...

Inflation Reduction Act proves positive boost for biosimilar...

FDA knocks back Zealand's dasiglucagon once again

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory

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