Mar 13, 2026
Summary Bristol Myers Squibb’s SOTYKTU has received FDA approval for adults with active psoriatic arthritis, becoming the first and only TYK2 inhibitor authorized for this indication. The drug extends its reach beyond its 2022 approval for moderate-to-severe plaque psoriasis, reinforcing BMS’s bid to b...
Read More...
Jun 17, 2025
Celltrion Announces FDA Approval of New STEQEYMA Presentation, Expanding Pediatric Dosing Options Celltrion, Inc. has announced that the FDA has approved an additional presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, in a 45mg/0.5mL single-dose vial for subcutaneous injection. This new formu...
Read More...
Sep 24, 2024
FDA Greenlights Zevra Therapeutics’ MIPLYFFA for Niemann-Pick Disease Type C Zevra Therapeutics, Inc. has announced that the FDA has approved MIPLYFFA (arimoclomol) capsules as the first oral treatment for Niemann-Pick disease type C. Indicated for use alongside miglustat, MIPLYFFA is intended for both adult and...
Read More...
Mar 11, 2024
Giant-cell arteritis (GCA), alternatively referred to as temporal arteritis, is a form of vasculitis primarily impacting arteries, particularly those in proximity to the temples. If left untreated, it may result in notable complications such as loss of vision. Diagnosis of the disease is often complicated by its pr...
Read More...
Oct 28, 2022
Psoriatic arthritis (PsA) is a type of chronic inflammatory arthritis that affects approximately 1 in every 10 people with psoriasis. According to the National Psoriasis Foundation, psoriasis is most common in adults aged 30 to 50. However, psoriatic arthritis can develop at any age, including children. Accordin...
Read More...
Jan 25, 2022
Merck’s Chronic Cough Med Gefapixant Receives A Red Flag From the FDA, Requests For More Data On 24th January 2022, Merck & Co. announced FDA rejection for its New Drug Application (NDA) of Gefapixant (experimental drug) for unexplained or chronic cough. FDA asked for additional information on the drug, rela...
Read More...
The Next Wave of Radioligand Therapies: 5 Candidates to Watch
Mar 20, 2026
Emerging TIL Therapies Poised to Broaden the Landscape Beyond AMTAGVI
Mar 06, 2026
Newsletter/Whitepaper