Browsing Tag
United States Food and Drug Administration
35 posts
Does Priority Review signal a commercial breakthrough for Protagonist Therapeutics, Inc.?
Takeda and Protagonist secure FDA Priority Review for rusfertide in PV. Explore the strategic, financial, and competitive implications now.
Why Scholar Rock believes apitegromab could still become a major SMA therapy despite FDA delays
Scholar Rock targets a 2026 BLA resubmission and potential launch for apitegromab in spinal muscular atrophy. Discover what it means for the SMA market.
BioMarin Pharmaceutical (Nasdaq: BMRN) secures FDA approval to expand PALYNZIQ use in adolescents with phenylketonuria
Find out how BioMarin Pharmaceutical Inc.’s FDA approval for adolescent PALYNZIQ use could reshape PKU treatment and long-term disease control.
AbbVie Inc. (NYSE: ABBV) wins FDA approval for Venclexta and acalabrutinib in first-line chronic lymphocytic leukemia
AbbVie Inc. secures FDA approval for Venclexta plus acalabrutinib in first-line CLL. Find out why this decision matters for patients, payers, and investors.
Savara Inc. (NASDAQ: SVRA) moves closer to first approval as FDA files MOLBREEVI BLA with priority review
Savara Inc. has secured FDA priority review for MOLBREEVI in autoimmune PAP. Find out what this means for approval odds, investors, and rare lung care.
Will pneumatic tooth movement gain traction in cosmetic orthodontics?
Dror Ortho-Design secures FDA clearance for ZSmile. Will pneumatic orthodontics reshape cosmetic aligner economics? Read the full executive analysis.
How FDA approval of SIGNA MRI upgrades could influence imaging economics
GE HealthCare wins FDA approval for SIGNA MRI upgrades. Explore how this could reshape hospital imaging economics and capital strategy.
Will pharmacokinetics data support 240 cm2 treatment fields for Ameluz?
Biofrontera Inc. advances Ameluz toward 240 cm2 FDA review. Explore the regulatory, financial, and competitive stakes in dermatology markets.
FDA clearance of Stealth AXiS highlights growing demand for unified spine surgery platforms
Medtronic plc wins FDA clearance for Stealth AXiS. Discover how unified spine robotics could reshape hospital strategy and investor expectations.
What KBroVet’s full FDA approval means for Pegasus Laboratories and the veterinary neurology market
Pegasus Laboratories secures full FDA approval for KBroVet, redefining canine epilepsy treatment. Find out what this milestone means for vets and pet owners.