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424 News Found

Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US
News | March 07, 2025

Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US

There are 38.4 million people with diabetes in the United States


Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Drug Approval | February 27, 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure


Biocon Biologics launches Yesintek Biosimilar to Stelara in US
News | February 25, 2025

Biocon Biologics launches Yesintek Biosimilar to Stelara in US

YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis


USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
Drug Approval | February 21, 2025

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated


Sanofi updates on extraintestinal pathogenic E. coli vaccine phase 3 clinical study
News | February 17, 2025

Sanofi updates on extraintestinal pathogenic E. coli vaccine phase 3 clinical study

No safety signals related to the vaccine candidate were identified


Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution
News | February 11, 2025

Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution

Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension
Drug Approval | February 10, 2025

NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension

TFOS is indicated for the treatment of pulmonary arterial hypertension


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP
News | January 22, 2025

Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP

According to IQVIATM sales data for the 12-month period ending November 2024, the Vitamin K1 Injectable Emulsion USP, 10 mg/mL market achieved annual sales of approximately $19.7 million