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RSS FeedPosted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 31 Mar 2026
Zymeworks receives US FDA fast track designation for ZW191, a folate receptor alfa targeting antibody drug conjugate
30 March 2026 - Zymeworks today announced that the US FDA has granted fast track designation to ZW191, an antibody ...
Posted by Michael Wonder on 30 Mar 2026
Elevar Therapeutics announces FDA acceptance for review of new drug application for lirafugratinib as second-line cholangiocarcinoma treatment
30 March 2026 - Elevar Therapeutics today announced that the US FDA has completed its filing review of the new drug ...
Posted by Michael Wonder on 28 Mar 2026
Egetis announces FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 feficiency
27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application ...
Posted by Michael Wonder on 27 Mar 2026
Awiqli approved in the US, the first and only once weekly basal insulin treatment for adults with type 2 diabetes
27 March 2026 - Novo Nordisk expects to launch Awiqli nationwide in the US in the second half of 2026. ...
Posted by Michael Wonder on 25 Mar 2026
Triana Biomedicines’ TRI-611 granted US FDA fast track designation for treatment of ALK positive non-small cell lung cancer
25 March 2026 - Triana Biomedicines today announced that the US FDA granted fast track designation for TRI-611, an investigational molecular ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves drug to treat neurologic manifestations of Hunter syndrome
25 March 2026 - The US FDA approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (mucopolysaccharidosis type II ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
25 March 2026 - Today, the FDA approved relacorilant (Lifyorli, Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel ...
Posted by Michael Wonder on 22 Mar 2026
IntraBio announces submission of supplemental new drug application for levacetylleucine for ataxia-telangiectasia
20 March 2026 - IntraBio today announced the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 21 Mar 2026
Toward greater transparency at the FDA - now is the time to act
18 March 2026 - The US FDA has generally sought to uphold the highest standards of scientific rigour in its regulation ...
Posted by Michael Wonder on 20 Mar 2026
Political influence ‘a serious problem’ for FDA under Trump, former commissioner says
19 March 2026 - Political influence ‘a serious problem’ for FDA under Trump, former commissioner says. ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...
Posted by Michael Wonder on 20 Mar 2026
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients with acquired hypothalamic obesity
19 March 2026 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to ...
Posted by Michael Wonder on 20 Mar 2026
FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma
20 March 2026 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine for ...
Posted by Michael Wonder on 19 Mar 2026
FDA approves fourth product under National Priority Voucher Program, higher dose semaglutide
19 March 2026 - The US FDA today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy ...