Approvals

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 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.

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

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.

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

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

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.

Cosette Pharmaceuticals and Alembic Pharmaceuticals are among the latest firms to have benefited from 180 days of competitive generic therapy exclusivity under the US FDA’s CGT pathway. Since the first approval in 2018, almost 500 ANDAs referencing CGT products have been approved.

Hengrui’s relafupu-α (SHR-1701), a bifunctional fusion protein against PD-L1 and TGF-βR2, has been approved in China in combination with chemotherapy as a first-line treatment for HER2-negative, PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma.

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.