Approvals

Pipeline Watch: Six Approvals And Four Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Novo Set To Make MASH Move On Madrigal In EU With Kayshild

The Danish drugmaker is getting ready to celebrate a first-in-class approval from the European Commission for semaglutide for metabolic dysfunction-associated steatohepatitis.

Pipeline Watch: Four Approvals And Three Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sun Pharma Lines Up Generic Wegovy As India’s Obesity Drug Market Opens

Sun Pharma’s generic Wegovy product has cleared regulatory review, positioning the company to enter India’s obesity drug market once patent protection lapses.

Pipeline Watch: One Approval And Five Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

IntraBio’s Aqneursa Succeeds In A-T Study, Scores European Nod For NPC

The company plans to take Aqneursa to regulators in the US, Europe and elsewhere for ataxia-telangiectasia (A-T), which currently lacks any approved therapy.

Pipeline Watch: One Approval And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Bio Usawa Scores Ghanian Approval For Its Lucentis Biosimilar

Bio Usawa continues to expand access to its Formycon/Bioeq-partnered ranibizumab biosimilar, landing its second approval in Africa.

Pipeline Watch: Three Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sanofi Ready To Roll Out Teizeild After EU Okay

The firm's type 1 diabetes drug has been given the green light by the European Commission.

Mabwell’s Humira Biosimilar Approved In Indonesia

The Indonesian health regulator has greenlit Mabwell’s adalimumab biosimilar, marking another global move for the Chinese firm.

Speedy Review/Approvals, R&D Support Key Items On Korea Policy Agenda This Year

A look back at South Korea's key biopharma policy and regulatory developments last year and the outlook for 2026, when AI tools look set to play a role in reducing product approval periods.