Regulatory Approval

CorTec's brain-computer interface gets FDA Breakthrough status, offering new hope for restoring movement in millions of chronic stroke survivors.

After three rejections, Outlook Therapeutics escalates its fight for US approval of a key wet AMD drug, already sold in Europe. Will the FDA bend?

A new minimally invasive stent for complex aortic arch disease receives FDA approval, offering hope to high-risk patients previously deemed untreatable.

FDA approves a pivotal trial for a novel heart valve, potentially revolutionizing treatment for millions with severe tricuspid regurgitation.

Royal Biologics' new Fibrinet system uses a patient's own blood to create a living bandage, a major step forward for treating diabetic and venous ulcers.

A new AI software that analyzes MRI scans has received a first-of-its-kind FDA classification, promising to help doctors differentiate complex brain disorders.

With diagnostic sales fueling a diverse therapeutic arsenal, Telix reaffirms blockbuster guidance and advances pivotal trials for prostate, brain, and kidney cancers.

Vyome is set to present promising Phase 2 data for VT-1953, a first-in-class treatment for a debilitating cancer complication with no approved drugs.

FDA clears Allevion's Vantage™, a disposable kit with integrated visualization that targets bone growth, aiming to transform spinal decompression.

Lipocine's stock plummets after its PPD drug fails a Phase 3 trial, but a promising signal in a patient subset offers a narrow path forward.

With key hires from Flatiron and Syneos, Target RWE signals major scaling plans in the booming real-world evidence market under new ownership.

With FDA approval for a pivotal trial, VDYNE advances its unique valve replacement system, offering new hope for millions with severe tricuspid regurgitation.

With a unique drug that preserves muscle while shedding fat, a newly fortified biotech is set to challenge the titans of the weight-loss market.

Parnell’s nixiFLOR, the first generic of Resflor Gold®, offers a cost-effective new weapon for ranchers battling Bovine Respiratory Disease.

A stark new benchmark study reveals poor survival in late-stage GvHD, just as MaaT Pharma’s microbiome therapy shows dramatically better outcomes.

Pantai Hospital KL's spot on Newsweek's 'World's Best' list highlights a national strategy built on superior quality, patient trust, and medical tourism.

Abbisko's irpagratinib gets EMA Orphan Drug status, fast-tracking a precision therapy for a hard-to-treat liver cancer subgroup with unmet needs.

Rinnai America promotes Perry McGuire, consolidating legal, lobbying, and HR as it battles regulations and champions 'consumer choice' in the appliance market.

The biopharma firm touts transformative drug data ahead, but with cash for only month-to-month operations, its future hangs by a precarious thread.

With FDA approval, soaring revenues, and game-changing clinical data, InspireMD prepares to spotlight its CGuard Prime stent for investors this April.