Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 52

Results For "ANDA"

2591 News Found

Datroway delivers first-ever overall survival breakthrough in 1st-line metastatic triple-negative breast cancer without immunotherapy
Clinical Trials | October 07, 2025

Datroway delivers first-ever overall survival breakthrough in 1st-line metastatic triple-negative breast cancer without immunotherapy

Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population


Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets
Drug Approval | October 07, 2025

Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy


FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL
Drug Approval | October 07, 2025

FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older


PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies
Biotech | October 07, 2025

PromoCell launches custom GMP cell culture media to power next-gen cell and gene therapies

New offering to debut at the 32nd ESGCT Congress, October 7–10, 2025, in Seville, Spain


Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups
Policy | October 06, 2025

Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups

States exhorted to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment


AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain
News | October 06, 2025

AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain

It represents a 30% increase in the company’s production capacity and introduces a segment dedicated to highly potent active ingredients


TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film
News | October 06, 2025

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder
News | October 04, 2025

AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder

Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors