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7003 News Found

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM
News | May 08, 2025

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets


AstraZeneca's enhertu improved pCR in early-stage breast cancer
News | May 07, 2025

AstraZeneca's enhertu improved pCR in early-stage breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care


Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site
Drug Approval | May 06, 2025

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice


Briefs: Tatva Chintan Pharma Chem and Shelter Pharma
News | May 06, 2025

Briefs: Tatva Chintan Pharma Chem and Shelter Pharma

Tatva Chintan Pharma Chem receives export order worth $35, 55,000


Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
News | May 06, 2025

Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma

IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma


Biocon Biologics secures strong market coverage for Yesintek in US
News | May 05, 2025

Biocon Biologics secures strong market coverage for Yesintek in US

Express Scripts has added YESINTEK to the National Preferred Formulary (NPF) effective March 21, 2025


Strides acquires identified ANDAs from Nostrum Laboratories, USA
News | May 03, 2025

Strides acquires identified ANDAs from Nostrum Laboratories, USA

The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs


AstraZeneca’s Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma
Clinical Trials | May 03, 2025

AstraZeneca’s Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma

Breztri is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease


Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP
Drug Approval | May 02, 2025

Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)


CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Clinical Trials | May 01, 2025

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings