News about Drug Discovery & Development

Phanes PT217 Gets Orphan Drug Designation for Neuroendocrine Carcinoma

PT217 is a first-in-class bispecific antibody targeting delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) being developed for patients with NEC.

Drug Discovery & Development | 17/08/2024 | By Aishwarya |  462

Lupin Secures Tentative Approval from FDA for Brimonidine Tartrate Ophthalmic Solution

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.025 percent (OTC).

Drug Discovery & Development | 16/08/2024 | By Aishwarya |  1001

Citius Pharma Subsidiary Acquires TenX Keane to Establish Citius Oncology

Citius Pharmaceuticals, Inc. has completed the previously announced merger of its oncology subsidiary with TenX Keane Acquisition (TenX).

Drug Discovery & Development | 14/08/2024 | By Aishwarya |  642

Evotec Announces Progress in its Collaboration with Bristol Myers Squibb

Evotec and Bristol Myers Squibb entered their strategic neuroscience collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases where there remains a significant unmet medical need for therapies that slow down or reverse disease progression.

Drug Discovery & Development | 12/08/2024 | By Aishwarya |  560

Alembic Pharma Secures US FDA Approval for Acitretin Capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. (Stiefel).

Drug Discovery & Development | 12/08/2024 | By Aishwarya |  1057

T-Maximum Pharmaceutical Announces Latest Clinical Advances in Allogeneic CAR-T Cell Therapy

T-MAXIMUM is currently focusing on advanced-stage solid malignancies, with its lead pipeline product for recurrent high-grade glioma (rHGG) demonstrating breakthrough efficacy and manageable safety in initial clinical studies and obtained Orphan Drug Designation (ODD) from the US FDA.

Drug Discovery & Development | 09/08/2024 | By Aishwarya |  717

Amneal Pharma Gets US FDA Approval for CREXONT Extended-Release Capsules

CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.

Drug Discovery & Development | 08/08/2024 | By Aishwarya |  973

Lupin Gets Approval from US FDA for Prednisolone Acetate Ophthalmic Suspension

Lupin has secured approval from US FDA for its Abbreviated New Drug Application (ANDA) for Prednisolone Acetate Ophthalmic Suspension USP, 1 percent to market a generic equivalent of Pred Forte Ophthalmic Suspension, 1 percent, of AbbVie Inc.

Drug Discovery & Development | 07/08/2024 | By Aishwarya |  743

Lupin Completes Phase 3 Trials for Lucentis Biosimilar

Lupin has successfully completed a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis.

Drug Discovery & Development | 06/08/2024 | By Aishwarya |  720

Alembic Pharma Gets USFDA Final Approval for Nelarabine Injection

Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial).

Drug Discovery & Development | 05/08/2024 | By Aishwarya |  730