regulatory approval

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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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China clears its first drug for chronic hepatitis D

Huahui Health has won the first approval in China for a drug to treat chronic infections with hepatitis D virus.

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EU approves Otsuka's long-acting HAE drug Dawnzera

An EMA nod for Otsuka's Dawnzera offers EU patients with HAE a drug that can be self-administered by patients with up to eight weeks between doses.

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Sentynl gets first FDA approval for rare disease Menkes

Children with a devastating, rare disorder of copper metabolism, called Menkes disease, now have an FDA-approved treatment for the first time.

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

EU approval for new asthma drug Exdensur lifts GSK

Tenpoint eyes presbyopia drug launch after FDA nod

China clears its first drug for chronic hepatitis D

EU approves Otsuka's long-acting HAE drug Dawnzera

Sentynl gets first FDA approval for rare disease Menkes

Remepy's hybrid Parkinson's therapy poised for phase 3

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regulatory approval

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