Blog
RSS FeedPosted by Michael Wonder on 19 Jun 2026
Corcept resubmits new drug application for relacorilant as a treatment for patients with Cushing’s syndrome
17 June 2026 - Corcept Therapeutics today announced it has resubmitted its new drug application to the US FDA for ...
Posted by Michael Wonder on 19 Jun 2026
US FDA approves an additional indication for Capvaxive (pneumococcal 21-valent conjugate vaccine) in children and adolescents aged 2 through 17 at increased risk for pneumococcal disease
18 June 2026 - Merck today announced that the US FDA has approved an expanded indication for Capvaxive (pneumococcal 21-valent conjugate ...
Posted by Michael Wonder on 19 Jun 2026
FDA accepts supplemental biologics license application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma
18 June 2026 - Roche announced today that the US FDA has accepted the company’s supplemental biologics license application for Lunsumio ...
Posted by Michael Wonder on 18 Jun 2026
Outlook Therapeutics announces FDA acceptance of resubmitted biologics license application for ONS-5010/Lytenava (bevacizumab-vikg) as a treatment for wet AMD
16 June 2026 - Outlook Therapeutics today announced the US FDA has acknowledged receipt of the resubmission of the biologics ...
Posted by Michael Wonder on 17 Jun 2026
FDA approves first single dose generic treatment for influenza
17 June 2026 - The US FDA today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment ...
Posted by Michael Wonder on 17 Jun 2026
Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections
17 June 2026 - GSK and Spero Therapeutics today announced that the US FDA has approved Utebzi, an oral antibiotic for ...
Posted by Michael Wonder on 17 Jun 2026
RBI granted fast track designation by FDA, validating its direct to brain stem cell therapy for Alzheimer's disease
15 June 2026 - Regeneration Biomedical today announced that the US FDA has granted fast track designation to the company's ...
Posted 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 16 Jun 2026
Bayer’s Ambelvist (gadoquatrane) receives FDA approval for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in the central nervous system and non-CNS body region
15 June 2026 - Approval is supported by data from the Phase 3 QUANTI clinical studies, which demonstrated efficacy at a ...