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Results For "FDA"

1621 News Found

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


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


OneSource receives EIR with VAI classification from USFDA for BLD facility
Drug Approval | January 29, 2025

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies


Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS
Drug Approval | January 23, 2025

Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS

The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS


Kwality Pharmaceuticals receives SFDA GMP approval for 2 units
Drug Approval | January 22, 2025

Kwality Pharmaceuticals receives SFDA GMP approval for 2 units

This certification will open new markets for the Kwality Pharma


Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets
Drug Approval | January 21, 2025

Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets

The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru


Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo