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RSS FeedPosted by Michael Wonder on 25 Apr 2026
Belite Bio initiates rolling submission of new drug application to the US FDA for tinlarebant for the treatment of Stargardt disease
21 April 2026 - Belite expects to complete the new drug application submission in the second quarter of 2026. ...
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 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 22 Apr 2026
Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US
22 April 2026 - The US FDA has extended by up to three months the target action date for its review ...
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
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each with Padcev (enfortumab vedotin-ejfv), for cisplatin-eligible patients with muscle invasive bladder cancer
20 April 2026 - Merck today announced that the US FDA granted priority review for two supplemental biologics license applications for ...
Posted by Michael Wonder on 21 Apr 2026
FDA accepts application for Genentech’s Gazyva for the treatment of the most common form of lupus
20 April 2026 - Filing acceptance based on Phase 3 ALLEGORY data for Gazyva showing a significant reduction in disease activity ...
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 21 Apr 2026
US FDA grants priority review to sBLA for Padcev and Keytruda as peri-operative treatment for muscle invasive bladder cancer regardless of cisplatin eligibility
20 April 2026 - Astellas Pharma and Pfizer announced that the US FDA accepted for triority review a supplemental biologics license ...
Posted by Michael Wonder on 19 Apr 2026
Aicuris receives FDA priority review for pritelivir NDA
16 April 2026 - 26 - Aicuris Anti-infective Cures today announced that the US FDA has granted priority review for the ...
Posted by Michael Wonder on 16 Apr 2026
Savara announces the US FDA has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis
15 April 2026 - Savara today announced that the FDA has extended the review period for the molgramostim BLA in ...