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RSS FeedPosted by Michael Wonder on 23 Apr 2026
Debiopharm announces FDA fast track designation for lunresertib in combination with zedoresertib for genomic defined platinum-resistant ovarian cancer
23 April 2026 - Debiopharm today announced that the US FDA has granted fast track designation to the combination of its ...
Posted by Michael Wonder on 23 Apr 2026
Polaryx Therapeutics receives US FDA fast track designations for all four indications to be evaluated in the SOTERIA basket trial
21 April 2026 - Polaryx Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
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
CMS and FDA announce RAPID coverage pathway to accelerate patient access to life changing medical devices
23 April 2026 - New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices. ...
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
4Moving Biotech granted FDA fast track designation to 4P004, supporting an accelerated development pathway in knee osteoarthritis
22 April 2026 - 4Moving Biotech today announced that the US FDA has granted fast track designation to 4P004 for the ...
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 22 Apr 2026
Star Therapeutics receives FDA rare paediatric disease and breakthrough therapy designations for VGA039 in von Willebrand disease prophylaxis
21 April 2026 - VGA039 is a once monthly, subcutaneously self-administered investigational therapy for the treatment of bleeding disorders, initially being ...
Posted by Michael Wonder on 21 Apr 2026
BBOT granted US FDA fast track designation for BBO-11818 for the treatment of adult patients with advanced KRAS mutant pancreatic ductal adenocarcinoma
20 April 2026 - BridgeBio Oncology Therapeutics today announced that the US FDA has granted fast track designation to BBO-11818 for ...
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 ...