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3802 News Found

Daiichi Sankyo and Merck enter into global agreement for MK-6070
News | August 07, 2024

Daiichi Sankyo and Merck enter into global agreement for MK-6070

To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights


Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
News | August 06, 2024

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity


OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously
News | August 06, 2024

OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously

Revolutionary technology will further boost OneSource’s scientific services offerings


Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg
Drug Approval | August 06, 2024

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL
Drug Approval | August 03, 2024

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia


Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause
Drug Approval | August 01, 2024

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo


Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets
Drug Approval | August 01, 2024

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries


Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers
Drug Approval | July 31, 2024

Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers

The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2


Boehringer Ingelheim acquires Nerio Therapeutics for US$ 1.3bn
News | July 31, 2024

Boehringer Ingelheim acquires Nerio Therapeutics for US$ 1.3bn

Boehringer Ingelheim aims to develop this program as a potential key centerpiece component for its immuno-oncology portfolio