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Results For "ANDA"

3094 News Found

Experts call for precision diagnosis and standardised neonatal protocols
Hospitals | April 15, 2026

Experts call for precision diagnosis and standardised neonatal protocols

The perinatology CME at Navi Mumbai brought together more than 100 obstetricians, pediatricians, and neonatologists


Biocon appoints Mandar Ghatnekar as Chief Technology Officer
People | April 10, 2026

Biocon appoints Mandar Ghatnekar as Chief Technology Officer

Former Global Head of IT & Digital Transformation at Biocon Biologics steps into enterprise-wide technology leadership role


SRM Prime Hospital's India-first heart procedure saves 73-year-old after standard options fail
Hospitals | April 05, 2026

SRM Prime Hospital's India-first heart procedure saves 73-year-old after standard options fail

The patient, suffering from calcific severe aortic stenosis—a dangerous narrowing of the heart valve caused by calcium buildup—had run out of standard treatment options


Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL
Drug Approval | February 25, 2026

Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL

Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older


FDA rejects Vanda’s jet lag drug in current form
Drug Approval | January 12, 2026

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning


Caplin Point Labs acquires 10 ANDAs, targets $473M US market
News | January 03, 2026

Caplin Point Labs acquires 10 ANDAs, targets $473M US market

The portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025


Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


Revvity launch new somatic cancer reference standards to to boost precision in oncology diagnostics
R&D | November 12, 2025

Revvity launch new somatic cancer reference standards to to boost precision in oncology diagnostics

The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line


Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection
Drug Approval | October 24, 2025

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable


VectorBuilder Redefines Plasmid Standards with miniVec
R&D | October 08, 2025

VectorBuilder Redefines Plasmid Standards with miniVec

Conventional plasmids as a pharmaceutical material are not only suboptimal in safety and function, but exceedingly costly to produce, prohibitively