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Results For "phase-3"

686 News Found

FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Biotech | November 26, 2024

FDA approves BridgeBio’s Attruby for ATTR-CM treatment

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR


European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors
Drug Approval | November 21, 2024

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors


FDA approves VYALEV for adults living with advanced parkinson's disease
Drug Approval | October 18, 2024

FDA approves VYALEV for adults living with advanced parkinson's disease

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease


Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
News | October 14, 2024

Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP

Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO


USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B
Drug Approval | October 12, 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis


Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024
Biotech | September 25, 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity


10 year data for Merck’s Keytruda demonstrates sustained overall survival benefit versus Ipilimumab in advanced melanoma
Clinical Trials | September 16, 2024

10 year data for Merck’s Keytruda demonstrates sustained overall survival benefit versus Ipilimumab in advanced melanoma

At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab


Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC
Clinical Trials | September 16, 2024

Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC

KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival


Ifinatamab Deruxtecan continues to demonstrate promising response rates for lung cancer in Phase 2 Trial
Clinical Trials | September 09, 2024

Ifinatamab Deruxtecan continues to demonstrate promising response rates for lung cancer in Phase 2 Trial

Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients