designation

Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancerRoche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer

Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer

April 29, 2025 01:00 ET  | Source: F. Hoffmann-La Roche Ltd The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry…

5 days ago
Press Release: Chlamydia vaccine candidate granted fast track designation by the US FDAPress Release: Chlamydia vaccine candidate granted fast track designation by the US FDA

Press Release: Chlamydia vaccine candidate granted fast track designation by the US FDA

Chlamydia vaccine candidate granted fast track designation by the US FDA Chlamydia infection can contribute to pelvic inflammatory diseases in…

1 month ago
Cellphire Therapeutics CLPH-511 Fast Track Designation GrantedCellphire Therapeutics CLPH-511 Fast Track Designation Granted

Cellphire Therapeutics CLPH-511 Fast Track Designation Granted

FDA has granted CLPH-511 Fast Track Designation for the treatment of acute hemorrhage as an alternative to conventional platelets when…

2 months ago
Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

ROCKVILLE, Md. and SUZHOU, China, March 05, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical…

2 months ago
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and EuropeBioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe

Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe

FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH)ODD status may expedite drug candidate development and approvals…

2 months ago
Comanche Biopharma Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for CBP-4888, an Investigational siRNA Drug Candidate for the Treatment of sFlt1-mediated Preterm PreeclampsiaComanche Biopharma Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for CBP-4888, an Investigational siRNA Drug Candidate for the Treatment of sFlt1-mediated Preterm Preeclampsia

Comanche Biopharma Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for CBP-4888, an Investigational siRNA Drug Candidate for the Treatment of sFlt1-mediated Preterm Preeclampsia

January 30, 2025 05:00 ET  | Source: Comanche Biopharma ILAP aims to accelerate time to market, facilitating faster patient access…

3 months ago
Abacus Analytics Receives HFMA Peer Review DesignationAbacus Analytics Receives HFMA Peer Review Designation

Abacus Analytics Receives HFMA Peer Review Designation

CHICAGO, Jan. 17, 2025 (GLOBE NEWSWIRE) -- The Healthcare Financial Management Association (HFMA) recently reviewed Abacus Analytics’ “Usual, Customary and…

4 months ago
HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS and TAGRISSO Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor TherapyHUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS and TAGRISSO Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy

HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS and TAGRISSO Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)…

5 months ago
AlveoGene Receives Rare Pediatric Disease Designation (RPDD)from FDA for AVG-002, its Novel, Inhaled Gene Therapy forLethal Neonatal Surfactant Protein B (SP-B) DeficiencyAlveoGene Receives Rare Pediatric Disease Designation (RPDD)from FDA for AVG-002, its Novel, Inhaled Gene Therapy forLethal Neonatal Surfactant Protein B (SP-B) Deficiency

AlveoGene Receives Rare Pediatric Disease Designation (RPDD)from FDA for AVG-002, its Novel, Inhaled Gene Therapy forLethal Neonatal Surfactant Protein B (SP-B) Deficiency

Inherited SP-B deficiency is an ultra-rare monogenic cause of fatal respiratory distress syndrome in newborn infantsClinical estimates for SP-B deficiency…

6 months ago