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Aldeyra spies FDA filing ahead for dry eye drug reproxalap

Aldeyra Therapeutics' dogged persistence with its drug eye disease therapy reproxalap – despite mixed results in a phase 3 trial – may be paying off.

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Mallinckrodt's long haul with terlipressin in US ends in app...

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt.

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FDA starts review of first drug for alpha-mannosidosis, from...

The FDA has started a priority review of Chiesi 's velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the firs

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Pfizer's Omicron BA.4/BA.5 vaccine recommended by CHMP

Pfizer and BioNTech's COVID-19 vaccine targeting Omicron BA.4 and BA.5 has been recommended for authorisation by the EMA's human medicines committee, shortly after the panel gave its blessi

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BMS scores first approval for psoriasis therapy Sotyktu

Bristol-Myers Squibb's deucravacitinib – one of the main pipeline assets in its $74 billion takeover of Celgene in 2019 – has been approved in its first market as a treatme

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GSK's daprodustat will have to face FDA advisory committee

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug

Aldeyra spies FDA filing ahead for dry eye drug reproxalap

Mallinckrodt's long haul with terlipressin in US ends in app...

FDA starts review of first drug for alpha-mannosidosis, from...

Pfizer's Omicron BA.4/BA.5 vaccine recommended by CHMP

BMS scores first approval for psoriasis therapy Sotyktu

GSK's daprodustat will have to face FDA advisory committee

Hims & Hers buys Australian digital health firm for $1.15bn

How to meet your physicians where they are online

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