Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots:Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitableApproval was based on the P-III (TRuE-AD3) trial, evaluating Opzelura (BID) vs vehicle in over 300 children (≥2 to <12yrs.) with ADTrial met its 1EP with more…

ByRidhi RastogiOctober 16, 2025

NEWS

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Shots:BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolioAs per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…

ByRidhi RastogiOctober 15, 2025

NEWS

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

Shots:FDA approved Zoryve (0.05% roflumilast; QD) for pts (2-5yrs.) based on P-III (INTEGUMENT-PED), INTEGUMENT-OLE study & a P-I PK trial; commercially available by end of Oct 2025INTEGUMENT-PED (n=652) showed rapid disease clearance with benefits from Wk. 1, as 25.4% vs 10.7% achieved vIGA-AD Success & a 2-grade improvement at Wk. 4; trial also met all…

ByRidhi RastogiOctober 7, 2025

NEWS

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots:The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitablesNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…

ByDipanshu DixitSeptember 19, 2025

NEWS

Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis

Shots:The P-III (ASCEND) trial evaluated rocatinlimab (150 or 300mg, Q4W/Q8W) in ~2,600 atopic dermatitis pts who completed 24wks. in ROCKET trial program & continued for 32wks. in ASCEND, which will evaluate long-term safety & efficacy up to 104wks.Trial showed a favorable long-term safety profile (1EP) with low discontinuation rates due to AEs, consistent…

ByRidhi RastogiSeptember 9, 2025

NEWS

Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies

Shots:BMS & Bain Capital have launched a new independent biopharma company focused on autoimmune diseases, which will be backed by $300M funding commitment led by Bain & 5 immunology assets in-licensed from BMSAs per the deal, BMS will retain ~20% equity stake in the new company & is entitled to receive royalties & milestone payments for…

ByRidhi RastogiJuly 29, 2025

NEWS

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

Shots:The EC has approved Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs (≥12mos.)As part of the EU approval process, Elanco conducted an H2H non-inferiority study in 338 dogs across 25 sites in 4 countries, which showed that Zenrelia (QD) is at least…

ByRidhi RastogiJuly 25, 2025

NEWS

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Shots:LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received AdbryTrial met its 1EP, with higher proportion of…

ByRidhi RastogiJuly 10, 2025

NEWS

Apogee Therapeutics Reports P-II (APEX) Trial Data on APG777 for Atopic Dermatitis (AD)

Shots:Part A of P-II (APEX) trial assessed APG777 vs PBO in 123 mod. to sev. AD pts, which met its 1EP with 71% vs 33.8% EASI reduction as well as highest absolute & PBO-adjusted EASI-75 (66.9% vs 24.6%); results were consistent across disease severity, & EASI-75 at Wk. 16 reached 83.3% & 89.5% in…

ByRidhi RastogiJuly 7, 2025

VIEWPOINTS

Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots

Shots: Backed by positive results from the P-III ARCADIA study, Galderma’s Nemluvio recently received approval from the US FDA for patients with moderate to severe atopic dermatitis Nemluvio (nemolizumab) has previously been approved for the treatment of prurigo nodularis Christophe Piketty, VP, Head of Innovation, Therapeutic Dermatology, Global Clinical Sciences, Galderma, highlighted insights from the…

BySaurabh ChaubeyJune 30, 2025

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis

Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Apogee Therapeutics Reports P-II (APEX) Trial Data on APG777 for Atopic Dermatitis (AD)

Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots

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