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INSIGHTS+

The US FDA New Drug Approvals in February 2026 

Shots:  Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.  Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia  Overall, February 2026 reflected…
March 10, 2026

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NEWS

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
December 8, 2025

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NEWS

Cosmo and Glenmark Reports the EC Approval on Winlevi to Treat Acne Vulgaris Across 17 countries in EU 

 Shots:  The EC has approved Cosmo Pharmaceuticals and Glenmark Pharmaceuticals’ Winlevi (clascoterone 10 mg/g cream) for the Treatment of Acne Vulgaris in 17 countries in Europe  Winlevi is authorized in the EU for treating acne vulgaris in adults and adolescents aged 12 to <18 years, with adolescent use limited to facial application  Following approval, Glenmark will begin commercializing Winlevi across 17 European countries, including Belgium, France, Spain,…
December 1, 2025

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NEWS

LEO Pharma Reports Data from P-III Study of Delgocitinib Cream in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE)

Shots: LEO Pharma presented data from the P-III (DELTA TEEN) study, showing delgocitinib cream efficacy vs. cream vehicle in adolescents (12–17yrs.) with moderate to severe CHE; 63.5% achieved IGA-CHE treatment success vs. 29.2% with vehicle Delgocitinib cream also showed an edge across key 2EPs, including a ≥90% improvement (HECSI-90: 71.6% vs. 37.5%; HESD itch: 64.8%…
September 19, 2025

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MAGAZINE

PharmaShots Magazine-August-2025 Edition

Aesthetic and beauty industry, underplayed by cosmeceuticals, shapes a soaring market worth $312.33B. Cosmeceuticals are known for their medical benefits beyond cosmetics and typically come in the forms of topical creams, serums, and lotions Let’s unearth the secrets of cosmeceuticals like never before through engaging articles, illustrative infographics, regulatory updates, and much more [ps_download_button]  The…
August 14, 2025

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Chronic Dermatologic Care: Baldo Scassellati Sforzolini from Galderma in Conversation with PharmaShots
VIEWPOINTS

Chronic Dermatologic Care: Baldo Scassellati Sforzolini from Galderma in Conversation with PharmaShots

Shots:  Recently, the groundbreaking results from Galderma’s Phase III OLYMPIA 1 trial were published in JAMA Dermatology. The study evaluated nemolizumab in patients with moderate-to-severe active prurigo nodularis  The trial met all primary and secondary endpoints, with results aligning with those from the OLYMPIA 2 trial, reinforcing nemolizumab’s potential in achieving sustained improvements in the…
May 26, 2025

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Alumis & Kaken
NEWS

Alumis and Kaken Pharmaceutical Enter Collaboration & Licencing Deal for ESK-001’s Development & Commercialization in Japan

Shots: Alumis & Kaken have partnered to develop, manufacture, & market ESK-001 for dermatology in Japan, with an option to expand into rheumatology & GI diseases As per the deal, Kaken will handle development, approval & marketing of ESK-001 in Japan in exchange for $40M upfront & near-term co-development costs, with ~$140M in milestones & field…
March 25, 2025

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NEWS

Sun Pharma to Acquire Checkpoint Therapeutics For ~$355M

Shots: Sun Pharma to acquire Checkpoint Therapeutics for ~$355M to strengthen its onco-derm innovative portfolio with Unloxcyt (cosibelimab-ipdl); closing expected in Q2’25 As per the deal, Checkpoint stockholders will get $4.10 cash/share (~66% premium) upfront & CVR/share without interest allowing stockholders to receive additional $0.70 cash/share if Unloxcyt is approved before certain deadlines in…
March 10, 2025

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A Complete Account of EMA Approvals in 2024
INSIGHTS+

A Complete Account of EMA Approvals in 2024

Shots:   In 2024, EMA approved around 53 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, vaccines, diagnostic agents, pneumology, nephrology, hepatology, ophthalmology, and endocrinology   PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…
March 6, 2025

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