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
The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
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
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
Patients with BRCA mutations often face aggressive disease and poor prognosis
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