regulatory approval

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Ascendis scores FDA approval for weekly dwarfism drug

Children with achondroplasia will soon have the option of a once-weekly - rather than daily - injection, courtesy of Ascendis' newly approved Yuviwel.

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Hernexeos box, two pills, and pill bottle

Boehringer gets FDA's second 'national priority' approval

Boehringer Ingelheim's lung cancer drug Hernexeos has become the second medicine approved after an FDA national priority review.

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FDA clears first all-oral combo for first-line CLL treatment

AstraZeneca's Calquence and AbbVie/Roche's Venclexta have become the first all-oral, fixed-duration regimen for newly-diagnosed CLL.

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EU approval for new asthma drug Exdensur lifts GSK

EU approval takes GSK a step closer to fulfilling its blockbuster sales hopes for new long-acting respiratory drug Exdensur.

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Tenpoint eyes presbyopia drug launch after FDA nod

Tenpoint is set to join the US market for drugs to treat presbyopia, taking on rival therapies from AbbVie, Orasis, and LENZ with a dual-acting rival.

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