Tenpoint wants Yuvezzi to open a new UK presbyopia market, but another eye drop filed first
Tenpoint Therapeutics seeks UK authorisation for Yuvezzi, testing whether a dual-agent presbyopia eye drop can build a market beyond the United States.
Pharma & Biotech
Pharma & Biotech
Niagen wins twin rare-disease designations, but can NB4168 turn nicotinamide riboside evidence into a medicine?
Niagen Bioscience gains U.S. and EU rare-disease designations for NB4168, but human trials and proof of efficacy still lie ahead.
Pharma & Biotech
Could deupirfenidone beat an approved IPF drug? Celea starts the Phase 3 test that will decide
Celea Therapeutics has begun an unusually ambitious Phase 3 program designed to prove that deupirfenidone is superior, rather than merely comparable, to the established antifibrotic pirfenidone. The approximately 1,100-patient trial could support a United States registration application if successful, but its 2029 readout leaves the company facing a long development period and an increasingly competitive
Pharma & Biotech
Apnimed files for Nasdaq IPO as oral sleep apnea drug AD109 nears FDA review
Apnimed, Inc. has filed for an initial public offering in the United States as it prepares for a potentially decisive regulatory year for AD109, its once-nightly oral treatment for obstructive sleep apnea. The Cambridge, Massachusetts-based pharmaceutical company plans to list on the Nasdaq Global Market under the ticker APMD, although the number of shares, proposed
Pharma & Biotech
FDA approves Sanofi’s Sarclisa Escena with wearable injector for multiple myeloma
The United States Food and Drug Administration (FDA) has approved Sanofi’s Sarclisa Escena for subcutaneous administration through the CirCLIQ on-body injector, creating the first FDA-authorised anticancer treatment that can be delivered using a wearable injector. The regulator approved the fixed 1,400-milligram dose on July 9, 2026 for several multiple myeloma treatment combinations already supported by
Pharma & Biotech
Compass Pathways has stronger COMP360 data, but can psilocybin treatment scale?
Find out how Compass Pathways’ COMP360 Phase 3 data could shape regulated psilocybin treatment for depression.
Pharma & Biotech
UroGen Pharma has FDA clearance for UGN-501, but can an oncolytic virus work in bladder cancer?
Find out how UroGen Pharma’s UGN-501 could test oncolytic virus therapy for recurrent non-muscle invasive bladder cancer.
Pharma & Biotech
Gain Therapeutics has FDA clearance for GT-02287, but can biomarkers become real benefit?
Find out how Gain Therapeutics’ GT-02287 could test GCase restoration as a disease-modifying strategy for Parkinson’s disease.
Pharma & Biotech
Vera Therapeutics has FDA approval for TRUTAKNA, but the real test comes next
Find out how Vera Therapeutics’ TRUTAKNA approval could reshape IgA nephropathy treatment while key kidney data remain ahead.
Pharma & Biotech
XIAFLEX hit its Phase 3 goals, but can Keenova change plantar fibromatosis care?
Find out how Keenova’s XIAFLEX Phase 3 success could create the first approved drug for plantar fibromatosis.