Merck KGaA’s Cladribine capsules gain FDA fast track for rare neuromuscular disorder

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options

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

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme

Solara’s Mangalore facility clears FDA inspection with VAI status

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

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals

Roche’s Gazyva shows breakthrough efficacy in phase III lupus study

The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response