These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial
Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
Full approval will depend on verification of clinical benefit in a confirmatory trial
The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A
The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India
Patients with BRCA mutations often face aggressive disease and poor prognosis
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
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