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2476 News Found

USFDA issues Form 483 for Parawada unit of Laurus Labs
Drug Approval | October 30, 2022

USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.


Granules India plans H2 FY 2022-23 R&D spend in Rs. 80-90 Cr
News | October 30, 2022

Granules India plans H2 FY 2022-23 R&D spend in Rs. 80-90 Cr

The company's long-term strategy is on science, technology and innovation and the company's strategy relating to this is on track


Gland Pharma’s Q2 FY23 revenue stood at Rs. 1,044.4 Cr
News | October 27, 2022

Gland Pharma’s Q2 FY23 revenue stood at Rs. 1,044.4 Cr

Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


Novartis maintains growth momentum; Confirms FY’22 Group guidance
News | October 26, 2022

Novartis maintains growth momentum; Confirms FY’22 Group guidance

Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Marksans to acquire Tevapharm's bulk formulations business
News | October 12, 2022

Marksans to acquire Tevapharm's bulk formulations business

Plans to double its manufacturing footprint to bolster the growth


Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant
Drug Approval | October 09, 2022

Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant

The company increases its efficiency and is able to face the growing demand for its services.


Pfizer announces positive topline results from Phase 3 TALAPRO-2 trial
Clinical Trials | October 09, 2022

Pfizer announces positive topline results from Phase 3 TALAPRO-2 trial

Study achieves primary endpoint of radiographic progression-free survival