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RSS FeedPosted by Michael Wonder on 27 Apr 2026
Saphnelo approved in the US for subcutaneous self-administration as a new auto-injector for the treatment of systemic lupus erythematosus
27 April 2026 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once weekly auto-injector, ...
Posted by Michael Wonder on 25 Apr 2026
Grace Therapeutics provides regulatory update on new drug application for GTx-104
23 April 2026 - Grace Therapeutics today announced that the US FDA has issued a complete response letter for the Company’s ...
Posted by Michael Wonder on 23 Apr 2026
FDA approves first ever gene therapy for treatment of genetic hearing loss under National Priority Voucher Program
23 April 2026 - Groundbreaking AAV-based gene therapy offers potential treatment for patients with OTOF gene-associated severe-to-profound and profound hearing loss. ...
Posted by Michael Wonder on 23 Apr 2026
AbbVie provides update on trenibotulinumtoxinE (TrenibotE) biologics license application in the US
23 April 2026 - AbbVie today announced that it received a complete response letter from the US FDA regarding the ...
Posted by Michael Wonder on 23 Apr 2026
Otarmeni (lunsotogene parvec-cwha) approved by FDA as first and only gene therapy for genetic hearing loss; Regeneron to provide Otarmeni for free in the US
23 April 2026 - Regeneron Pharmaceuticals today announced the US FDA has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first ...
Posted by Michael Wonder on 23 Apr 2026
Labcorp launches FDA approved companion diagnostic to identify patients with ovarian cancer eligible for Keytruda
22 April 2026 - Labcorp today announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, the only companion ...
Posted by Michael Wonder on 22 Apr 2026
Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children
22 April 2026 - The US FDA has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication ...
Posted by Michael Wonder on 22 Apr 2026
Dupixent (dupilumab) approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria
22 April 2026 - Approval for children aged 2 to 11 years with chronic spontaneous urticaria who remain symptomatic despite H1 ...
Posted by Michael Wonder on 21 Apr 2026
FDA approves Merck’s once daily Idvynso (doravirine/islatravir)
21 April 2026 - Idvynso is the first and only non-INSTI, tenofovir free, once daily, complete two drug regimen to ...
Posted by Michael Wonder on 21 Apr 2026
First FDA approved treatment for patients with focal segmental glomerulosclerosis—a rare kidney condition
16 April 2026 - The US FDA on Monday approved a new indication for Filspari (sparsentan) tablets for reducing proteinuria in ...
Posted by Michael Wonder on 14 Apr 2026
Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the first and only approved medicine for FSGS
13 April 2026 - Travere Therapeutics today announced that the US FDA has approved Filspari (sparsentan) to reduce proteinuria in adult ...
Posted by Michael Wonder on 11 Apr 2026
FDA approves updated Vabysmo label to extend treatment for macular oedema following retinal vein occlusion beyond six months
9 April 2026 - Genentech has received US FDA approval of Vabysmo (faricimab-svoa) for the treatment of macular oedema due to ...
Posted by Michael Wonder on 10 Apr 2026
Replimune receives complete response letter from the FDA for RP1 biologics license application for the treatment of advanced melanoma
10 April 2026 - Replimune Group today announced that the company received a complete response letter from the US FDA ...
Posted by Michael Wonder on 10 Apr 2026
Foundayo (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the US
9 April 2026 - Foundayo, the only GLP-1 pill for weight loss that can be taken any time of day ...
Posted by Michael Wonder on 07 Apr 2026
FDA approves first generic dapagliflozin tablets
7 April 2026 - FDA approves multiple generics of Farxiga. ...