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Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Drug Approval | May 29, 2025

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’

Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA


Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor
News | May 29, 2025

Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor

MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume


Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification
News | May 28, 2025

Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification

Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs


Zydus Lifesciences’ ‘breast cancer awareness campaign reaches millions
News | May 27, 2025

Zydus Lifesciences’ ‘breast cancer awareness campaign reaches millions

Campaign empowers women to prioritise their health through thought provoking films, influencer-led campaigns, scientific and medical podcasts, survivor experiences, and digital awareness


Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK
News | May 26, 2025

Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK

YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde


CPHI & PMEC China sees surge in international attendance
News | May 24, 2025

CPHI & PMEC China sees surge in international attendance

Record international participation reflects renewed momentum in pharma manufacturing and global sourcing, as easing tariffs fuel growth


Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP
Drug Approval | May 24, 2025

Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP

Allopurinol is used to prevent or lower high uric acid levels in the blood


Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP
Drug Approval | May 24, 2025

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin


Zydus receives final approval from USFDA for Isotretinoin Capsules USP
Drug Approval | May 24, 2025

Zydus receives final approval from USFDA for Isotretinoin Capsules USP

Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne