Blog
RSS FeedPosted by Michael Wonder on 07 May 2025
Viridian Therapeutics receives FDA breakthrough therapy designation for veligrotug for the treatment of thyroid eye disease
7 May 2025 - Biologics license application submission for veligrotug on track for second half 2025 with a planned US ...
Posted by Michael Wonder on 06 May 2025
Rezolute receives breakthrough therapy designation from FDA for ersodetug in the treatment of hypoglycaemia due to tumour hyperinsulinism
5 May 2025 - Registrational study in patients with tumour hyperinsulinism expected to commence mid-year. ...
Posted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
Posted by Michael Wonder on 22 Apr 2025
FDA grants breakthrough therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
22 April 2025 - Breakthrough therapy designation is based on the encouraging survival data from the Phase 1 BrainChild-03 trial in ...
Posted by Michael Wonder on 17 Apr 2025
uniQure announces FDA breakthrough therapy designation granted to AMT-130 for the treatment of Huntington’s disease
17 April 2025 - Breakthrough therapy designation based on clinical evidence from Phase I/II trials showing meaningful slowing of disease progression. ...
Posted by Michael Wonder on 31 Mar 2025
IDEAYA Biosciences receives US FDA breakthrough therapy designation for darovasertib monotherapy in neo-adjuvant uveal melanoma
31 March 2025 - Breakthrough therapy application was supported by updated clinical data from Phase 2 neo-adjuvant uveal melanoma trial that ...
Posted by Michael Wonder on 30 Mar 2025
IBT is granted breakthrough therapy designation for its drug candidate
28 March 2025 - The US FDA has granted a breakthrough therapy designation for IBP-9414’s potential to reduce gastrointestinal-related mortality. ...
Posted by Michael Wonder on 26 Feb 2025
GRIN Therapeutics receives FDA breakthrough therapy designation for radiprodil
25 February 2025 - Company preparing to initiate Phase 3 pivotal trial. ...
Posted by Michael Wonder on 20 Feb 2025
PolarityBio receives US FDA breakthrough therapy designation for treatment of Wagner grade I diabetic foot ulcers
20 February 2025 - The FDA has granted breakthrough therapy designation for SkinTE based on key positive data from the Phase ...
Posted by Michael Wonder on 18 Feb 2025
Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma
18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...
Posted by Michael Wonder on 17 Feb 2025
Innate Pharma announces US FDA granted breakthrough therapy designation to lacutamab for relapsed or refractory Sézary syndrome
17 February 2025 - Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favourable safety profile in patients ...
Posted by Michael Wonder on 06 Feb 2025
Acrivon Therapeutics announces FDA has granted breakthrough device designation for ACR-368 OncoSignature assay for endometrial cancer
5 February 2025 - The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in ...
Posted by Michael Wonder on 28 Jan 2025
Beckman Coulter receives FDA breakthrough device designation for Alzheimer's disease blood test
28 January 2025 - Beckman Coulter today announced the US FDA has granted breakthrough device designation to Beckman Coulter's Access p‑Tau217/β-Amyloid ...
Posted by Michael Wonder on 22 Jan 2025
Bluejay Therapeutics receives US FDA breakthrough therapy designation for brelovitug (BJT-778) for the treatment of chronic hepatitis delta
21 January 2025 - Bluejay Therapeutics today announced that its lead product candidate brelovitug (also known as BJT-778) has received ...
Posted by Michael Wonder on 17 Jan 2025
Innovent receives NMPA breakthrough therapy designation for IBI343 (anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
16 January 2025 - Innovent Biologics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted ...