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Results For "U.S.-FDA"

291 News Found

Lupin launches first generic version of Oracea in US
News | April 10, 2024

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


Biocon Biologics secures US market entry date for Bmab 1200
Drug Approval | March 01, 2024

Biocon Biologics secures US market entry date for Bmab 1200

The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA


New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies
Clinical Trials | February 28, 2024

New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies

The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies


Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows achieved groundbreaking results in liver disease due to MASH
Clinical Trials | February 28, 2024

Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows achieved groundbreaking results in liver disease due to MASH

Survodutide has potential to become best-in-class treatment for metabolic dysfunction-associated steatohepatitis


Moderna posts Q4 2023 revenue at US$ 2.8 billion
News | February 23, 2024

Moderna posts Q4 2023 revenue at US$ 2.8 billion

Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance


Lupin launches Ganirelix Acetate Injection in US
News | February 16, 2024

Lupin launches Ganirelix Acetate Injection in US

It is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation


Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US
News | February 14, 2024

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of USD 15 million in the U.S.


Glenmark, Ichnos Sciences form ‘Ichnos Glenmark Innovation’ for new drug discovery in cancer treatment
News | January 30, 2024

Glenmark, Ichnos Sciences form ‘Ichnos Glenmark Innovation’ for new drug discovery in cancer treatment

This alliance brings together drug innovation capabilities of Glenmark and Ichnos to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors


Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab
News | January 29, 2024

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America