Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 02 May 2025
Pfizer’s ALK lung cancer drug Lorviqua lands first-line reimbursement in Korea
2 May 2025 - Pfizer Korea has secured reimbursement for Lorviqua (lorlatinib) as a first-line treatment for ALK-positive metastatic non-small ...
Posted by Michael Wonder on 01 May 2025
FDA grants OKYO Pharma fast track designation to urcosimod for neuropathic corneal pain
1 May 2025 - OKYO Pharma announces that the US FDA has granted fast track designation to urcosimod for the treatment ...
Posted by Michael Wonder on 01 May 2025
Up to 1,000 women a year could benefit from new at-home treatment for endometriosis
1 May 2025 - Our final draft guidance recommends linzagolix (Yselty, Theramex) with hormonal add-back therapy for adults of reproductive age ...
Posted by Michael Wonder on 01 May 2025
MHRA authorises cancer treatment variation with an administration time of 3–5 minutes
30 April 2025 - The MHRA has today approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), ...
Posted by Michael Wonder on 01 May 2025
AstraZeneca Korea reapplies for Lynparza reimbursement in prostate cancer
22 April 2025 - AstraZeneca Korea has recently reapplied for health insurance coverage for its PARP inhibitor Lynparza (olaparib) for ...
Posted by Michael Wonder on 30 Apr 2025
Q32 Bio announces FDA fast track designation granted to bempikibart (ADX-914) for the treatment of alopecia areata
30 April 2025 - Q32 Bio today announced that the US FDA has granted fast track designation to Q32 Bio's bempikibart ...
Posted by Michael Wonder on 30 Apr 2025
Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis
30 April 2025 - First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and paediatric generalised myasthenia gravis. ...
Posted by Michael Wonder on 30 Apr 2025
SMC - April 2025 decisions
7 April 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 30 Apr 2025
US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa
29 April 2025 - Rare paediatric disease priority review voucher granted by FDA. ...
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 29 Apr 2025
BioInvent receives FDA fast track designation for BI-1808 for the treatment of cutaneous T-cell lymphoma
29 April 2025 - BioInvent today announces that the US FDA has granted fast track designation to BI-1808, a first-in-class ...
Posted by Michael Wonder on 29 Apr 2025
Incyclix Bio granted US FDA fast track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for ...
Posted by Michael Wonder on 29 Apr 2025
Innorna announces FDA rare paediatric disease designation granted to IN013 for treatment of Wilson disease
25 February 2025 - Innorna is thrilled to announce that the US FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 29 Apr 2025
Institute for Clinical and Economic Review to assess treatments for obesity management
29 April 2025 - Report will be subject of New England CEPAC meeting in November 2025; draft scoping document open ...
Posted by Michael Wonder on 29 Apr 2025
Rinvoq (upadacitinib) receives US FDA approval for giant cell arteritis
29 April 2025 - Rinvoq (upadacitinib) is now the first and only oral Janus kinase inhibitor approved for the treatment of ...