Business, energy, technology, markets and global industry news from Business News Today

U.S. Food and Drug Administration

PharmaDeviceNews U.S. Food and Drug Administration
Representative image of EEG-guided brain stimulation as Wave Neuroscience’s MeRT FDA clearance puts biomarker-led PTSD treatment, neuromodulation, and precision psychiatry under sharper focus.
Medical Devices & Diagnostics

Wave Neuroscience FDA clearance puts EEG-guided PTSD treatment closer to clinical adoption

Find out how Wave Neuroscience’s MeRT FDA clearance could reshape biomarker-guided PTSD treatment and precision psychiatry.

Read More
Representative image of CT imaging analysis as Subtle Medical’s SubtleHD(CT) FDA clearance puts AI-powered image enhancement, radiology workflows, and scanner efficiency under sharper focus.
Medical Devices & Diagnostics

Subtle Medical wins FDA clearance for CT software as scanner pressure intensifies

Find out how Subtle Medical’s FDA-cleared SubtleHD(CT) could reshape AI-powered CT image enhancement and radiology workflows.

Read More
Representative image of a sleep medicine setting as Apnimed’s AD109 oral therapy advances debate over obstructive sleep apnea treatment, Phase 3 data, and potential FDA review.
Pharma & Biotech

Apnimed advances oral OSA therapy case as AD109 heads toward FDA decision window

Find out how Apnimed’s AD109 Phase 3 data could reshape oral treatment for obstructive sleep apnea as FDA review approaches.

Read More
Representative image: A clinician reviews spinal imaging as Zetagen Therapeutics’ ZetaMet Phase 2a data highlights investigational progress in treating metastatic breast cancer patients with lytic bone lesions.
Pharma & Biotech

Can Zetagen’s ZetaMet Phase 2a data change how metastatic breast cancer bone lesions are treated?

Find out how Zetagen’s ZetaMet Phase 2a data may reshape treatment of metastatic breast cancer bone lesions.

Read More
Pharma & Biotech

Entyvio pediatric filing puts Takeda at the centre of the next IBD treatment debate

Find out how Takeda’s pediatric Entyvio review could change biologic treatment choices in ulcerative colitis and Crohn’s disease.

Read More
Pharma & Biotech

Why FDA approval for Hepcludex changes the treatment landscape for hepatitis delta virus

Find out how FDA approval for Gilead Sciences’ Hepcludex could reshape chronic hepatitis delta virus treatment in the U.S.

Read More
Representative image: A surgical team prepares a preserved donor heart in a high-tech transplant setting, reflecting the clinical and regulatory stakes behind United Therapeutics Corporation’s FDA-cleared UHeart xenotransplantation trial for end-stage heart failure.
Pharma & Biotech

Why United Therapeutics’ FDA-cleared UHeart trial could redefine xenotransplantation risk

Find out how United Therapeutics’ FDA-cleared UHeart trial could reshape xenotransplantation for end-stage heart failure patients.

Read More
Pharma & Biotech

Why Tempus’ tumor-only xT CDx approval could matter for precision oncology testing

Find out how Tempus’ tumor-only xT CDx FDA approval could expand precision oncology testing and reshape solid tumor profiling.

Read More
Pharma & Biotech

How Pharming’s Joenja resubmission could reopen the FDA pathway for pediatric APDS treatment

Find out how Pharming’s Joenja sNDA resubmission could reopen the FDA pathway for younger children with APDS.

Read More
Representative image of a clinical researcher reviewing rare disease therapy data, as Beren Therapeutics faces an extended FDA decision timeline for adrabetadex in infantile-onset Niemann-Pick disease type C.
Pharma & Biotech

Why the FDA extended its adrabetadex review and what it means for Beren Therapeutics

Adrabetadex faces a longer FDA review in infantile-onset NPC. The delay could shape rare-disease drug standards in 2026.

Read More