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1369 News Found

Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year


European Commission expands Jemperli plus chemotherapy approval for endometrial cancer
Drug Approval | January 21, 2025

European Commission expands Jemperli plus chemotherapy approval for endometrial cancer

Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population


Moderna announces updates on pandemic influenza program
News | January 21, 2025

Moderna announces updates on pandemic influenza program

The project will provide additional support for late-stage development and licensure of pre-pandemic mRNA-based vaccines


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


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


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


Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies
Clinical Trials | January 10, 2025

Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

QUANTI clinical development program evaluated the efficacy and safety of the investigational MRI contrast agent gadoquatrane for a broad range of potential indications and in pediatric and adult patients