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Results For "prophylaxis"

72 News Found

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg
Drug Approval | August 13, 2024

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals


Novo Nordisk's H1 sales increased by 24% in Danish kroner
News | August 12, 2024

Novo Nordisk's H1 sales increased by 24% in Danish kroner

For the 2024 outlook, sales growth is now expected to be 22-28% at CER


Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate
Clinical Trials | July 26, 2024

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis


European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population


Supernova Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19
Clinical Trials | May 20, 2024

Supernova Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19

SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients


Granules India announced ANDA Approval for Colchicine Capsules
Drug Approval | May 01, 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines