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RSS FeedPosted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 11 Jan 2026
Aquestive Therapeutics announces regulatory development for Anaphylm (dibutepinephrine) sublingual film
9 January 2026 - Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at ...
Posted by Michael Wonder on 11 Jan 2026
Camurus announces FDA acceptance of NDA resubmission for Oclaiz for the treatment of acromegaly
9 January 2026 - Camurus today announced that the US FDA has accepted for review the company's resubmission of the new ...
Posted by Michael Wonder on 09 Jan 2026
VectorY Therapeutics receives FDA fast track designation for VTx-002, a first in class vectorised antibody targeting underlying disease biology in ALS
8 January 2026 - VectorY Therapeutics announced today that the US FDA has granted fast track designation for VTx-002, a first-in-class ...
Posted by Michael Wonder on 09 Jan 2026
Revolution Medicines announces FDA breakthrough therapy designation for zoldonrasib
8 January 2026 - First breakthrough therapy designation for an investigational drug specifically targeting KRAS G12D mutation in non-small cell lung ...
Posted by Michael Wonder on 09 Jan 2026
858 Therapeutics announces FDA fast track designation for PARG inhibitor ETX-19477 for the treatment of patients with BRCA mutated, platinum resistant ovarian cancer
8 January 2026 - 858 Therapeutics today announced that the US FDA has granted fast track designation to ETX-19477, the company’s ...
Posted by Michael Wonder on 09 Jan 2026
Alessa Therapeutics announces FDA fast track designation for Enolen, a first of its kind treatment for localised prostate cancer
8 January 2026 - Alessa Therapeutics today announced that the US FDA has granted fast track designation for Enolen, the ...
Posted by Michael Wonder on 09 Jan 2026
Complement Therapeutics announces FDA fast track designation for CTx001 for the treatment of geographic atrophy secondary to AMD
8 January 2025 - Complement Therapeutics today announced that the US FDA has granted fast track designation for CTx001, the company's ...
Posted by Michael Wonder on 08 Jan 2026
Vanda Pharmaceuticals announces receipt of FDA decision letter on Hetlioz supplemental new drug application for jet lag disorder
8 January 2026 - Vanda Pharmaceuticals today announced that it has received a decision letter from the US FDA's Center for ...
Posted by Michael Wonder on 08 Jan 2026
FDA approves new 2 gram presentation of Fibryga, enhancing convenience and precision in treating acquired fibrinogen deficiency
7 January 2026 - Octapharma today announced that the US FDA has approved a new 2 g presentation of Fibryga, fibrinogen ...
Posted by Michael Wonder on 08 Jan 2026
Vera Therapeutics announces US FDA granted priority review to biologics license application for atacicept for treatment of adults with IgA nephropathy
7 January 2026 - Vera Therapeutics today announced the atacicept biologics license application for the treatment of adults with immunoglobulin A ...
Posted by Michael Wonder on 07 Jan 2026
Biosplice announces the submission of its new drug application to the FDA for lorecivivint to treat knee osteoarthritis
6 January 2026 - Biosplice Therapeutics announced today that it has submitted its new drug application to the FDA for approval ...
Posted by Michael Wonder on 06 Jan 2026
Oculis announces US FDA breakthrough therapy designation granted to privosegtor for treatment of optic neuritis
6 January 2026 - Oculis today announced that its neuroprotective candidate privosegtor was granted breakthrough therapy designation by the US FDA ...
Posted by Michael Wonder on 06 Jan 2026
Alixorexton granted breakthrough therapy designation by US FDA for the treatment of narcolepsy type 1
6 January 2026 - Alkermes today announced that the US FDA has granted breakthrough therapy designation to alixorexton for the ...
Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for ...