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FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
News | November 24, 2025

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels


India’s Diabetes Crisis: Awareness and monitoring gaps threaten millions
Healthcare | November 21, 2025

India’s Diabetes Crisis: Awareness and monitoring gaps threaten millions

According to the ICMR-INDIAB study, 11.4% of adults in India have type 2 diabetes, while a staggering 15.3% are pre-diabetic


AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
Drug Approval | November 21, 2025

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study


Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg
Drug Approval | November 14, 2025

Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis


Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Drug Approval | November 14, 2025

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg

Dexlansoprazole delayed-release capsules are a proton pump inhibitor


Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg
Drug Approval | November 05, 2025

Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde


ACG to invest $200 million in US hard-shell capsule manufacturing
News | October 22, 2025

ACG to invest $200 million in US hard-shell capsule manufacturing

The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta


FDA approves Lupin’s Lenalidomide capsules
Drug Approval | September 17, 2025

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma