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RSS FeedPosted by Michael Wonder on 23 Jun 2026
Achieve Life Sciences receives complete response letter from FDA for cytisinicline NDA
22 June 2026 - Achieve Life Sciences today announced that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 23 Jun 2026
Allergan Aesthetics receives approval for Boey (trenibotulinumtoxinE) in Canada, the first and only rapid-onset, short-duration neurotoxin for the temporary improvement of frown lines in adult patients
23 June 2026 - Today, Allergan Aesthetics announced Health Canada has approved Boey (trenibotulinumtoxinE) for the temporary improvement in the ...
Posted 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
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 17 Jun 2026
Health Canada approves Zepbound as the first ever obstructive sleep apnea medication in Canada for adults living with obesity
16 June 2026 - Eli Lilly Canada announced today that Health Canada has approved Zepbound (tirzepatide injection) for the treatment of ...
Posted by Michael Wonder on 17 Jun 2026
Exdensur (depemokimab injection) approved in Canada for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps
16 June 2026 - GSK announced today that Health Canada has approved Exdensur (depemokimab) for two indications. ...
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
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 ...
Posted by Michael Wonder on 16 Jun 2026
Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer
12 June 2026 - Roche announced today that the Ventana PTEN (SP218) RxDx Assay is the first immunohistochemistry companion diagnostic test ...