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The US FDA has approved Yesintek 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, a biosimilar version of Stelara (ustekinumab)
Yesintek is indicated for mod. to sev. plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older, and for mod. to sev. active Crohn’s disease and ulcerative colitis in adults
Yesintek was initially approved in November 2024
Ref: Biocon…
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Almirall & CrystalO have partnered to advance drug discovery research in medical dermatology, leveraging CrystalO's scientific expertise in ion channels with Almirall's experience in medical dermatology R&D
As per the deal, CrystalO will use its AI & structure-based drug discovery platform for compound discovery, optimization, IND-enabling studies, & early clinical development through PoC. Almirall…
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Pfizer reported positive topline results from the pivotal P-III TRANQUILLO and TRANQUILLO 2 studies evaluating LITFULO (ritlecitinib) in pts. with NSV. Both studies (n=2,174 pts) met their co-primary endpoints, demonstrating statistically significant improvements in facial and total body repigmentation vs. PBO at 52 wks. across 271 sites globally
TRANQUILLO (n=607, ≥12yrs.) evaluated 50mg LITFULO and TRANQUILLO…
Hair restoration sits at an unusual intersection of dermatology, surgery, and regenerative medicine. For most of the past two decades the category attracted limited industry attention in India, growing in pockets rather than as a structured specialty. That has changed. The discipline has matured into a recognisable healthcare segment with consolidating clinical standards, identifiable centres of excellence, and a…
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HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026
Trial met its 1EP of improved durable response rates (66% vs 15%),…
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Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines
Trial showed higher CR rates at Wk. 12 across symptomatic dermographism (29.3% vs 14%), cold urticaria (56.3% vs 14.6%), & cholinergic urticaria (29.3% vs 15.8%), with responses emerging as early as Wk.…
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The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks.
Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…
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Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO
Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…
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LEO Pharma has entered into a definitive agreement to acquire Replay, expanding its dermatology pipeline with Replay’s herpes simplex virus-based gene therapy platform for rare genetic skin disorders
As per the deal, LEO will acquire Replay for $50M upfront, plus milestone payments & tiered single-digit royalties, while adding Replay’s HSV design and manufacturing expertise…
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The EC has approved Rhapsido (Remibrutinib) for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment
Approval was supported by P-III (REMIX-1 & 2) trials (n=925) in CSU pts, where remibrutinib showed superior improvements in itch, hives & weekly urticaria activity at Wk.12 vs PBO in pts uncontrolled on H1-antihistamines, with a favorable safety profile…

