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RSS FeedPosted by Michael Wonder on 30 Apr 2026
US FDA grants priority review to BeOne Medicines’ Tevimbra in first-line HER2 positive gastro-oesophageal adenocarcinoma
29 April 2026 - BeOne Medicines today announced that the US FDA has granted priority review to a supplemental biologics ...
Posted by Michael Wonder on 30 Apr 2026
Immunome nnounces submission of new drug application to US FDA for varegacestat for the treatment of adults with desmoid tumours
29 April 2026 - Immunome today announced the submission of a new drug application to the US FDA for varegacestat, an ...
Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review of new drug application for Gilead’s once daily HIV treatment of bictegravir plus lenacapavir
29 April 2026 - Gilead Sciences today announced the US FDA accepted its new drug application submission for bictegravir 75 mg/lenacapavir ...
Posted by Michael Wonder on 29 Apr 2026
Intellia Therapeutics initiates rolling submission of biologics license application to FDA for lonvoguran ziclumeran as a one time treatment for hereditary angioedema
27 April 2026 - Expect to complete biologics license application submission in second half of 2026; anticipate launch in first ...
Posted by Michael Wonder on 28 Apr 2026
AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata
28 April 2026 - Submission is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the ...
Posted by Michael Wonder on 28 Apr 2026
Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older
28 April 2026 - Approval based on KALOS and LOGOS Phase 3 trials demonstrating statistically significant and clinically meaningful benefits of ...
Posted by Michael Wonder on 28 Apr 2026
FDA grants priority review for Imavvy (nipocalimab-aahu) as the potential first approved treatment for people living with warm auto-immune haemolytic anaemia
27 April 2026 - Johnson & Johnson announced today that the US FDA has granted priority review to the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2 positive locally advanced or metastatic gastric cancer
27 April 2026 - Jazz Pharmaceuticals today announced that the US FDA accepted for filing with priority review the supplemental biologics ...
Posted by Michael Wonder on 27 Apr 2026
AbbVie submits regulatory application to FDA for Skyrizi (risankizumab-rzaa) subcutaneous induction for adults with moderately to severely active Crohn's disease
27 April 2026 - Submission supported by data from Phase 3 pivotal AFFIRM study. ...
Posted 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
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 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 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 ...