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

The company is addressing these observations comprehensively

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

Cipla Health launches Astaberry's campaign 'Get the Rich Look'

The campaign celebrates radiant, healthy skin that shines naturally, empowering women to step forward with confidence in every walk of life.

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

IMCD and Friesland Campina Professional expand distribution agreement across EMEA

Friesland Campina Professional’s innovative Kievit portfolio features fat powders, creamers, foamers, whipping agents, cake emulsifiers

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials