Pharmaceuticals

Pharmaceuticals
Medical Devices

PRF Technologies wins FDA IND clearance for OcuRing-K cataract trial

PRF Technologies says FDA has cleared its IND for OcuRing-K, enabling a Phase II trial in cataract surgery patients expected to begin enrolling in
PRF Technologies says FDA has cleared its IND for OcuRing-K, enabling a Phase II trial in cataract surgery patients expected to begin enrolling in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Quoin Pharma lines up four QRX009 rapamycin studies for 2026

Quoin Pharmaceuticals is launching investigator-led trials of its topical rapamycin in three rare skin diseases and plans a first IND filing by Q3 2026.
Quoin Pharmaceuticals is launching investigator-led trials of its topical rapamycin in three rare skin diseases and plans a first IND filing by Q3 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Cell & Gene Therapy

Regeneron Q1 2026 revenues rise 19% on Dupixent and new approvals

Regeneron posted $3.6bn in Q1 revenues and secured three FDA approvals, including the first gene therapy for genetic hearing loss.
Regeneron posted $3.6bn in Q1 revenues and secured three FDA approvals, including the first gene therapy for genetic hearing loss.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Rein Therapeutics enrolls first patients in Phase 2 IPF trial

Eight patients are now enrolled in the RENEW study of inhaled peptide LTI-03, with sites active in the US, Australia, and Poland.
Eight patients are now enrolled in the RENEW study of inhaled peptide LTI-03, with sites active in the US, Australia, and Poland.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Santhera proposes Dr Srishti Gupta for board ahead of May AGM

The Swiss rare-disease pharma is putting the former Idorsia CEO forward as an independent director at its 26 May annual general meeting.
The Swiss rare-disease pharma is putting the former Idorsia CEO forward as an independent director at its 26 May annual general meeting.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 data at ECIO 2026

The Fort Lauderdale biotech reported an 87% overall response rate in a 15-patient Phase 1 study and is advancing to Phase 2 in metastatic
The Fort Lauderdale biotech reported an 87% overall response rate in a 15-patient Phase 1 study and is advancing to Phase 2 in metastatic
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals

Tempest Therapeutics to present TPST-2003 CAR-T data at ISCT 2026

Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
The Biotech Times Editorial Team  · 
Pharmaceuticals

Teva Q1 2026: AUSTEDO hits $578m as brands offset generics slide

Teva posted $4.0bn in Q1 revenues as AUSTEDO, AJOVY and UZEDY collectively grew 41%, cushioning a sharp fall in lenalidomide generics.
Teva posted $4.0bn in Q1 revenues as AUSTEDO, AJOVY and UZEDY collectively grew 41%, cushioning a sharp fall in lenalidomide generics.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Teva to acquire Emalex Biosciences for up to $900m in neuroscience bet

Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.
Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.
The Biotech Times Editorial Team  · 
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