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Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.
Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
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Telix and Regeneron have entered into a collaboration to jointly develop and commercialize next-generation radiopharmaceutical therapies
Telix will receive a $40M upfront from Regeneron for four initial programs, with options to expand. The companies will share commercialization costs and profits, while Telix may opt to earn up to $535M per program in development and…
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Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies
As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…
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The EC has approved Dupixent to treat mod. to sev. CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, and CUPIDKids
Study A & C assessed Dupixent (LD → 300mg Q2W or 200mg Q2W for…
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Eli Lilly has reported that Foundayo is now available in the US, along with lifestyle intervention for obese/overweight adults with weight-related medical problems. Foundayo is now available via LillyDirect and telehealth, with US retail rollout starting today
Approval was backed by the ATTAIN program, including ATTAIN-1 (n= 3127), where Foundayo showed weight loss of…
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Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season
Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination
Nuvaxovid…
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Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.
Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
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Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia
Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph
Denoza will be available in a prefilled syringe format
Ref: Apotex | Image: Apotex | Press Release…
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The EC has approved Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg) across EEA markets
Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women
Preclinical and clinical data show that estetrol (E4) has…
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The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT
Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC
Imdylltra is…

