regulatory approval

News

J&J's Tecvayli claims third national priority FDA approval

J&J claims the FDA's third national priority voucher approval, advancing a Tecvayli-based regimen for multiple myeloma into the second-line setting.

News

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.

News

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.

News

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.

News

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.

News

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.

J&J's Tecvayli claims third national priority FDA approval

Ascendis scores FDA approval for weekly dwarfism drug

Boehringer gets FDA's second 'national priority' approval

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

LSX2026: On promise and patience, with Hans Schambye

Using AI-driven synthetic personas to take your insights fur...

regulatory approval

Editor's Picks