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Results For "PLI"

2909 News Found

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
Drug Approval | June 27, 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations


Lupin launches Prucalopride tablets in US
Drug Approval | June 27, 2025

Lupin launches Prucalopride tablets in US

Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA


Ashland expands viatel bioresorbable polymers offering for medical devices
Medical Device | June 26, 2025

Ashland expands viatel bioresorbable polymers offering for medical devices

Viatel bioresorbable polymers are increasingly used in dental and orthopedic implants


Covestro launches localized production of medical-grade TPU in Asia Pacific
Medical Device | June 25, 2025

Covestro launches localized production of medical-grade TPU in Asia Pacific

Changhua site meets international regulatory standards for global medical applications


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Lupin receives USFDA approval for Prucalopride Tablets
Drug Approval | June 25, 2025

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults


Archish Fertility & IVF partners with Amaha Health for patient support and mental wellbeing
Healthcare | June 24, 2025

Archish Fertility & IVF partners with Amaha Health for patient support and mental wellbeing

This collaboration ensures that patients receive comprehensive care, including emotional and psychological support throughout their fertility journey


Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Diagnostic Center | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy


BASF opens new GMP Solution Center in US
News | June 23, 2025

BASF opens new GMP Solution Center in US

BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America


AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study
Diagnostic Center | June 21, 2025

AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month