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RSS FeedPosted by Michael Wonder on 28 Apr 2026
Bepirovirsen accepted for priority review and granted breakthrough therapy designation by the US FDA
28 April 2026 - 26 October 2026 assigned by FDA as PDUFA date. ...
Posted by Michael Wonder on 28 Apr 2026
Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older
28 April 2026 - Approval based on KALOS and LOGOS Phase 3 trials demonstrating statistically significant and clinically meaningful benefits of ...
Posted by Michael Wonder on 28 Apr 2026
FDA approves Caplyta (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
27 April 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental new ddrug application based ...
Posted by Michael Wonder on 28 Apr 2026
FDA grants priority review for Imavvy (nipocalimab-aahu) as the potential first approved treatment for people living with warm auto-immune haemolytic anaemia
27 April 2026 - Johnson & Johnson announced today that the US FDA has granted priority review to the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
Terns Pharmaceuticals announces FDA breakthrough therapy designation granted to TERN-701 for certain patients with chronic myeloid leukaemia
27 April 2026 - Terns Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to TERN-701, a novel, oral ...
Posted by Michael Wonder on 28 Apr 2026
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2 positive locally advanced or metastatic gastric cancer
27 April 2026 - Jazz Pharmaceuticals today announced that the US FDA accepted for filing with priority review the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
Prothena announces Novo Nordisk obtains fast track designation from the US FDA for coramitug (PRX004) in ATTR amyloidosis with cardiomyopathy
27 April 2026 - Prothena today announced that the US FDA has granted fast track designation to coramitug, a potential best ...
Posted by Michael Wonder on 28 Apr 2026
GSK’s investigational liver therapy, efimosfermin, receives US FDA breakthrough therapy and EMA Priority Medicines (PRIME) designations for MASH
27 April 2026 - GSK today announced that efimosfermin, a once monthly investigational liver therapy, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 27 Apr 2026
AbbVie submits regulatory application to FDA for Skyrizi (risankizumab-rzaa) subcutaneous induction for adults with moderately to severely active Crohn's disease
27 April 2026 - Submission supported by data from Phase 3 pivotal AFFIRM study. ...
Posted by Michael Wonder on 27 Apr 2026
Saphnelo approved in the US for subcutaneous self-administration as a new auto-injector for the treatment of systemic lupus erythematosus
27 April 2026 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once weekly auto-injector, ...
Posted by Michael Wonder on 25 Apr 2026
Bristol Myers Squibb and Pfizer to make Eliquis (apixaban) available via Mark Cuban Cost Plus Drug Company
24 April 2026 - Expands Options for Cash-Paying Patients to Access the Nation’s #1 Prescribed Oral Blood Thinner ...
Posted by Michael Wonder on 25 Apr 2026
Belite Bio initiates rolling submission of new drug application to the US FDA for tinlarebant for the treatment of Stargardt disease
21 April 2026 - Belite expects to complete the new drug application submission in the second quarter of 2026. ...
Posted by Michael Wonder on 25 Apr 2026
Grace Therapeutics provides regulatory update on new drug application for GTx-104
23 April 2026 - Grace Therapeutics today announced that the US FDA has issued a complete response letter for the Company’s ...
Posted by Michael Wonder on 25 Apr 2026
FDA accelerates action on treatments for serious mental illness following executive order
24 April 2026 - Agency issues priority vouchers, clears new clinical research, and advances guidance to support treatments for depression, PTSD, ...
Posted by Michael Wonder on 23 Apr 2026
FDA approves first ever gene therapy for treatment of genetic hearing loss under National Priority Voucher Program
23 April 2026 - Groundbreaking AAV-based gene therapy offers potential treatment for patients with OTOF gene-associated severe-to-profound and profound hearing loss. ...