The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Shots: The US FDA has accepted the NDA & granted priority review to zasocitinib (TAK-279) for the treatment of adults with mod. to sev. plaque psoriasis (PsO), with the PDUFA target action date in Q1’27. MAA is under EMA’s review, with further global filings planned NDA was supported by extensive data incl. global P-III (Latitude…

ByRidhi RastogiSeptember 14, 2026

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Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara)

Shots: 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…

ByRidhi RastogiAugust 18, 2026

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Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

ByRidhi RastogiJuly 30, 2026

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InnoCare Reports P-III Trial Findings on Fadeucravacitinib in Plaque Psoriasis

Shots: InnoCare has reported a P-III trial assessing the efficacy, safety & tolerability of fadeucravacitinib (ICP-488) vs PBO in pts with moderate-to-severe plaque psoriasis Trial met its 1EP with statistically significant & clinically meaningful improvement, while also achieving multiple 2EPs, demonstrating consistent efficacy across measures; data to be presented & published in the future Fadeucravacitinib…

ByRidhi RastogiJuly 28, 2026

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Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi RastogiJuly 17, 2026

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Merck Reports the US FDA Approval for Lipfendra (Enlicitide) to Reduce LDL-C in Adults with Hypercholesterolemia

Shots: The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from…

ByRidhi RastogiJuly 17, 2026

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Junshi Biosciences Licenses Roconkibart to Fosun Wanbang in Greater China

Shots: Junshi Biosciences has entered into a license agreement with Fosun Wanbang Pharma Group for roconkibart in the Greater China region, incl. Mainland China, Hong Kong SAR, Macao SAR, & Taiwan Companies will cooperate on the development, registration, manufacturing & commercialization of roconkibart, an anti-IL-17A mAb, which showed 91% reached PASI 90 at wk. 16…

ByRidhi RastogiJuly 2, 2026

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Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: 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…

ByRidhi RastogiJune 12, 2026

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Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Shots: 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…

ByRidhi RastogiJune 12, 2026

NEWS

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…

ByRidhi RastogiMay 20, 2026

The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara)

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

InnoCare Reports P-III Trial Findings on Fadeucravacitinib in Plaque Psoriasis

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Merck Reports the US FDA Approval for Lipfendra (Enlicitide) to Reduce LDL-C in Adults with Hypercholesterolemia

Junshi Biosciences Licenses Roconkibart to Fosun Wanbang in Greater China

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

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