Blog
RSS FeedPosted by Michael Wonder on 24 Jun 2026
Cemdisiran regulatory submissions accepted for review by FDA and EMA for the treatment of generalised myasthenia gravis
22 June 2026 - Regeneron Pharmaceuticals today announced that both the US FDA and EMA have accepted the regulatory applications for ...
Posted by Michael Wonder on 24 Jun 2026
Teva submits NDA for ecopipam, a first in class investigational therapy for paediatric Tourette syndrome
18 June 2026 - Teva Pharmaceutical Industries today announced the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 24 Jun 2026
BioMendics receives FDA fast track designation for BM-3103 (TolaSure Gel) for epidermolysis bullosa simplex
23 June 2026 - BioMendics today announced that the US FDA has granted fast track designation to BM-3103, formulated as TolaSure ...
Posted by Michael Wonder on 24 Jun 2026
Calico Life Sciences announces fosigotifator granted breakthrough therapy designation by the US FDA for the treatment of vanishing white matter disease
23 June 2026 - Calico Life Sciences today announced that the US FDA granted fosigotifator breakthrough therapy designation for the treatment ...
Posted by Michael Wonder on 23 Jun 2026
ViiV Healthcare advances paediatric HIV regulatory submissions with FDA priority review for Tivicay PD and EMA validation of marketing application for Tivicay
22 June 2026 - ViiV Healthcare today announced that the US FDA has accepted the supplemental new drug application to ...
Posted by Michael Wonder on 23 Jun 2026
Prime Medicine receives US FDA regenerative medicine advanced therapy designation for PM359 for the treatment of chronic granulomatous disease
22 June 2026 - Prime Medicine today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 23 Jun 2026
US WorldMeds receives full US FDA approval of Tecelra (afamitresgene autoleucel) with an expanded indication, extending the first approved engineered T-cell therapy for a solid tumour to children as young as 12
22 June 2026 - US WorldMeds announced that the US FDA has granted full approval of Tecelra (afamitresgene autoleucel) and ...
Posted by Michael Wonder on 23 Jun 2026
Praxis Precision Medicines receives FDA breakthrough therapy designation for elsunersen for the treatment of seizures associated with SCN2A developmental and epileptic encephalopathy caused by gain of function variants
22 June 2026 - -- Praxis Precision Medicines today announced that the US FDA has granted breakthrough therapy designation for elsunersen ...
Posted by Michael Wonder on 23 Jun 2026
FDA grants rolling review of Palvella’s Qtorin rapamycin NDA for microcystic lymphatic malformations
22 June 2026 - Palvella Therapeutics announced today that FDA has granted rolling review for the Company’s new drug application for ...
Posted by Michael Wonder on 23 Jun 2026
Regulators often diverge from FDA on expedited oncology approvals
22 June 2026 - Among oncology drugs first approved by the US FDA, other regulatory authorities varied in how they ...
Posted 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 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 ...