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RSS FeedPosted by Michael Wonder on 17 Jun 2026
Qihan Biotech's QT-019B Receives FDA RMAT and BTD
16 June 2026 - Hangzhou Qihan Biotech today announced that its internally developed universal dual-target CAR-T therapy, QT-019B, has officially received ...
Posted by Michael Wonder on 17 Jun 2026
NovaBridge Biosciences receives FDA fast track designation for givastomig in first-line HER2 negative metastatic gastric cancer
16 June 2026 - NovaBridge Biosciences today announced that the US FDA has granted fast track designation to givastomig in combination ...
Posted by Michael Wonder on 17 Jun 2026
Inhibrx announces US FDA acceptance of BLA for ozekibart in patients with conventional chondrosarcoma
15 June 2026 - Inhibrx Biosciences today announced that the US FDA has accepted for filing its biologics license application seeking ...
Posted by Michael Wonder on 17 Jun 2026
FDA broadens access to over the counter naloxone nasal spray for opioid overdose
16 June 2026 - The US FDA today approved another over the counter intranasal naloxone product, Rextovy, a 4 mg naloxone ...
Posted by Michael Wonder on 16 Jun 2026
Halia Therapeutics receives FDA fast track designation for ofirnoflast (HT-6184) in lower-risk myelodysplastic syndromes
15 June 2026 - Designation follows Phase 2 data showing durable transfusion independence and multilineage hematological improvement; full results presented ...
Posted by Michael Wonder on 16 Jun 2026
US FDA accepts Gilead’s application for investigational once weekly oral Yeztugo, potentially the first long-acting pill for HIV prevention
15 June 2026 - Gilead Sciences today announced the US FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg ...
Posted by Michael Wonder on 16 Jun 2026
FDA approves Colorado’s plan to import cheaper drugs from Canada
15 June 2026 - Florida became first state to receive approval, in 2024, but has yet to start importing drugs. ...
Posted by Michael Wonder on 15 Jun 2026
Belite Bio completes rolling submission of new drug application to US FDA for tinlarebant for the treatment of Stargardt disease type 1
12 June 2026 - Belite Bio today announced the completion of its rolling submission of a new drug application to ...
Posted by Michael Wonder on 15 Jun 2026
US FDA grants orphan drug and rare paediatric disease designations to GEn1E Lifesciences’ dual signal modulator for the treatment of Duchenne muscular dystrophy
9 June 2026 - GEn1E Lifesciences today announced that the US FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 15 Jun 2026
Ultomiris granted priority review in the US as treatment for adults with immunoglobulin A nephropathy
15 June 2026 - Based on I CAN Phase 3 trial results from prespecified interim analysis in which Ultomiris demonstrated 43.4% ...
Posted by Michael Wonder on 14 Jun 2026
Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly
10 June 2026 - Camurus today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 14 Jun 2026
Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes
12 June 2026 - Approval based on the PROTECT phase 3 study and additional data from the global clinical development program ...
Posted by Michael Wonder on 13 Jun 2026
FDA approves capivasertib with abiraterone and prednisone for PTEN deficient androgen pathway modulation-naïve or -sensitive prostate cancer
12 June 2026 - Today, the FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with ...
Posted by Michael Wonder on 12 Jun 2026
FDA grants priority review for Genentech’s Tecentriq for a certain type of stage III colon cancer
10 June 2026 - Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application filing for ...
Posted by Michael Wonder on 12 Jun 2026
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
12 June 2026 - Today, the FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and ...