Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer

Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively

Lupin launches Loteprednol Etabonate ophthalmic suspension 0.5% in US

Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroidresponsive inflammatory conditions of the palpebral and bulbar conjunctiva

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards

Plant-based chemistry essential for home and personal care products: Vishal Sharma, Executive Director & Chief Executive Officer (Chemicals), Godrej Industries

Plant-based chemistries have an outsized role to play for the HPC sector by meeting demand for good, gentle, and green products

WHO, ITU, and WIPO release new report on AI use in traditional medicine

The global TCIM market is expected to reach nearly US$ 600 billion by 2025

Valneva lifts EMA’s temporary restriction on use of chikungunya vaccine IXCHIQ in elderly

The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection