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723 News Found

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


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Apotex acquires US rights to PROVIGIL and NUVIGIL
News | January 13, 2025

Apotex acquires US rights to PROVIGIL and NUVIGIL

PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107
Clinical Trials | January 09, 2025

Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107

The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs


Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Innovent receives NMPA approval for Taletrectinib Adipate capsule from NMPA
Drug Approval | January 02, 2025

Innovent receives NMPA approval for Taletrectinib Adipate capsule from NMPA

DOVBLERON marks the 13th addition to Innovent’s commercial portfolio


Innovent inks agreement with Roche for Novel DLL3 ADC
News | January 02, 2025

Innovent inks agreement with Roche for Novel DLL3 ADC

Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009


Venus Remedies secures GMP certification for antibiotic carbapenem facility in Moldova
Drug Approval | January 01, 2025

Venus Remedies secures GMP certification for antibiotic carbapenem facility in Moldova

Expects to unlock further opportunities in the Moldovan market, contributing anticipated sales of $300,000 in 2025 and approximately $700,000–$800,000 in 2026


Merck inks agreement with Hansoh Pharma for investigational Oral GLP-1 receptor agonist
News | January 01, 2025

Merck inks agreement with Hansoh Pharma for investigational Oral GLP-1 receptor agonist

Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535