Tag: regulatory approval

EB612, a first-in-class long-acting PTH(1-34) oral peptide  for hypoparathyroidism, produced robust bioavailability and sustained increases in calcium across three preclinical models; IND is expected in late 2026

International Petroleum Corporation (IPC) (TSX, Nasdaq Stockholm: IPCO) is pleased to announce first oil has been achieved at Phase 1 of the Blackrod project, ahead of schedule and on budget.

TORONTO, June 15, 2026 (GLOBE NEWSWIRE) -- International Petroleum Corporation (IPC) (TSX, Nasdaq Stockholm: IPCO) is pleased to announce first oil has been achieved at Phase 1 of the Blackrod project, ahead of schedule and on budget.

Data show investigational atumelnant drove sustained androgen reductions while enabling lowering of glucocorticoid supplementation to physiologically normal levels in adults with classic CAH

– Lorundrostat was associated with significant reductions in heart failure risk biomarkers in a proteomic analysis of data from participants with uncontrolled hypertension –

– Verekitug, administered once every three months, led to clinically meaningful improvements in nasal polyp score (NPS) in approximately 80% of participants –

Media Release

COPENHAGEN, Denmark; June 13, 2026

SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio^®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53,000 people in the U.S. alone, and there are currently no approved treatment options for the disease.

NEWTOWN, Pa., June 12, 2026 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW, the Company), a clinical-stage biopharmaceutical company developing novel therapies for critical global viral threats, today announced that the planned test of tivoxavir marboxil (TXM) in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Emphasis remains on commitment to transparency, customer protection and community engagement