The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots: FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks. ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

NEWS

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR) Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…

ByRidhi RastogiMay 23, 2025

NEWS

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under review MATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiMay 23, 2025

NEWS

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Shots: Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…

ByRidhi RastogiMay 22, 2025

NEWS

China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL

Shots: InnoCare Pharma has approved Minjuvi (tafasitamab) + Lenalidomide, followed by Minjuvi monotx., for treating adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT) Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, combined with lenalidomide, is already approved for treating eligible DLBCL pts. in Hong Kong, Macau,…

ByDipanshu DixitMay 21, 2025

NEWS

Novavax’s NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19

Shots: FDA has approved the BLA for Nuvaxovid against COVID-19 in adults (≥65yrs.) & individuals (12-64yrs.) with at least one underlying condition increasing risk of sev. COVID-19 based on a P-III trial, showing favorable safety & efficacy; commercially available in US this fall pending strain selection at FDA VRBPAC meeting on May 22, 2025 FDA…

ByRidhi RastogiMay 20, 2025

NEWS

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 19, 2025

NEWS

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots: The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA states Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025) 

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)  This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Animal Health. Check out our full report below:     Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis Read More: J&J AstraZeneca Reports…

ByRidhi RastogiMay 16, 2025

NEWS

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…

ByRidhi RastogiMay 16, 2025

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL

Novavax’s NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

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