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FDA panel votes against Intarcia’s GLP-1 implant

Intarcia Therapeutics’ take on the massively successful GLP-1 agonist class of diabetes drugs has failed to convince an FDA advisory committee, which voted unanimously aga

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Menarini brings oral SERD to Europe with Orserdu okay

Menarini has secured EU approval for Orserdu, the first in a new class of oral selective oestrogen receptor degrader (SERD) drugs and the first innovation in endocrine the

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EU has its first RoActemra biosimilar, from Fresenius Kabi

The European Commission has approved the first biosimilar version of Actemra/RoActemra, Roche’s $3 billion blockbuster, from German drugmaker Fresenius Kabi.

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FDA declines to approve needle-free epinephrine from ARS

Shares in ARS Pharmaceuticals were in freefall in pre-market trading this morning as it emerged that the FDA had declined to approve its application for its lead product,

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ViiV’s injectable HIV PrEP drug Apretude gets EU okay

People in the EU who need access to pre-exposure prophylaxis (PrEP) for HIV could soon have a new option with fewer doses after the European Commission approved ViiV Healt

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Pfizer’s alopecia drug gets EU nod, chasing Lilly’s Olumiant

Pfizer has picked up approval in the EU for Litfulo, its JAK inhibitor for severe alopecia areata, extending its challenge to Eli Lilly’s first-to-market Olumiant.

FDA panel votes against Intarcia’s GLP-1 implant

Menarini brings oral SERD to Europe with Orserdu okay

EU has its first RoActemra biosimilar, from Fresenius Kabi

FDA declines to approve needle-free epinephrine from ARS

ViiV’s injectable HIV PrEP drug Apretude gets EU okay

Pfizer’s alopecia drug gets EU nod, chasing Lilly’s Olumiant

Severino takes the helm at Sarepta after turbulent spell

Discover a new era of healthcare panel engagement: Grounded ...

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