Could Capitan Orthopedics’ SupraSpacer reshape irreparable rotator cuff tear treatment?
Rotator cuff care has a treatment gap. Capitan Orthopedics’ SupraSpacer now has FDA breakthrough status, but evidence will decide adoption.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
FDA clears Theradaptive’s OASIS pivotal trial as spinal fusion graft race enters a new phase
Spine biologics has long lacked fresh competition. Theradaptive’s OsteoAdapt SP trial could test whether that market is ready to move.
Medical Devices & Diagnostics
Can ZETA SURGICAL turn brain biopsy and hydrocephalus procedures into point-of-care care?
Neurosurgery needs precision beyond elite hospitals. ZETA SURGICAL’s FDA clearance puts AI-guided access to the real-world test.
Medical Devices & Diagnostics
Why 3Shape’s Dx Software clearance matters for digital dentistry’s next phase
Dental AI is moving from scan capture to diagnosis support. 3Shape Dx now faces the harder test of U.S. clinician adoption.
Medical Devices & Diagnostics
FDA clears Olympus POWERSEAL Open Extended Jaw as surgical energy competition grows
Olympus cleared a new POWERSEAL device, but adoption now depends on surgeon trust, hospital value reviews, and open surgery workflow gains.
Pharma & Biotech
Rezolute’s ersodetug data deepens the congenital hyperinsulinism regulatory debate
Rezolute, Inc. has presented expanded Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism at the Pediatric Endocrine Society Annual Meeting, adding continuous glucose monitoring outcomes and open-label extension observations to a program that previously missed its primary endpoint. The update places the late-stage rare disease biotech firm in a complex regulatory position, as the
Pharma & Biotech
How Arvinas and Pfizer’s VEPPANU approval tests the commercial future of PROTAC drugs
Arvinas Inc., with partner Pfizer Inc., has received U.S. Food and Drug Administration approval for VEPPANU, also known as vepdegestrant, for adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer after disease progression following at least one line of endocrine therapy. The approval gives the oncology market its
Pharma & Biotech
Can Arvinas, Inc. and Pfizer Inc. scale protein degradation in oncology markets
FDA approves VEPPANU, the first PROTAC therapy. Discover how Arvinas, Inc. is reshaping breast cancer treatment strategies today.
Pharma & Biotech
Does Rhythm Pharmaceuticals, Inc. now lead the rare neuroendocrine obesity treatment space?
Discover how Rhythm Pharmaceuticals, Inc.’s EU approval of setmelanotide could redefine rare obesity treatment and what comes next for the market.
Pharma & Biotech
Is Noema Pharma AG building a multi-symptom menopause therapy platform with cendifensine?
Is Noema Pharma AG building a menopause therapy platform? Discover how cendifensine could reshape non-hormonal treatment strategies