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RSS FeedPosted 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. ...
Posted by Michael Wonder on 23 Apr 2026
Debiopharm announces FDA fast track designation for lunresertib in combination with zedoresertib for genomic defined platinum-resistant ovarian cancer
23 April 2026 - Debiopharm today announced that the US FDA has granted fast track designation to the combination of its ...
Posted by Michael Wonder on 23 Apr 2026
Polaryx Therapeutics receives US FDA fast track designations for all four indications to be evaluated in the SOTERIA basket trial
21 April 2026 - Polaryx Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 23 Apr 2026
AbbVie provides update on trenibotulinumtoxinE (TrenibotE) biologics license application in the US
23 April 2026 - AbbVie today announced that it received a complete response letter from the US FDA regarding the ...
Posted by Michael Wonder on 23 Apr 2026
CMS and FDA announce RAPID coverage pathway to accelerate patient access to life changing medical devices
23 April 2026 - New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices. ...
Posted by Michael Wonder on 23 Apr 2026
Otarmeni (lunsotogene parvec-cwha) approved by FDA as first and only gene therapy for genetic hearing loss; Regeneron to provide Otarmeni for free in the US
23 April 2026 - Regeneron Pharmaceuticals today announced the US FDA has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first ...
Posted by Michael Wonder on 23 Apr 2026
Labcorp launches FDA approved companion diagnostic to identify patients with ovarian cancer eligible for Keytruda
22 April 2026 - Labcorp today announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, the only companion ...
Posted by Michael Wonder on 22 Apr 2026
4Moving Biotech granted FDA fast track designation to 4P004, supporting an accelerated development pathway in knee osteoarthritis
22 April 2026 - 4Moving Biotech today announced that the US FDA has granted fast track designation to 4P004 for the ...