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 unsuitable sNDA 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

Biogen’s Zurzuvae Receives the EC’s Approval to Treat Severe Postpartum Depression

Shots: The EC has approved Zurzuvae (zuranolone) for the treatment of postpartum depression in adults following MHRA’s approval in Aug 2025 Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…

ByRidhi RastogiSeptember 18, 2025

NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…

ByRidhi RastogiSeptember 18, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:   AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC Read More: AstraZeneca Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L…

ByRidhi RastogiSeptember 12, 2025

NEWS

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Shots: The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome Designation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorable Additionally, ION582 is being investigated in…

ByRidhi RastogiSeptember 12, 2025

NEWS

Ferring Reports the PMDA’s NDA Acceptance of Nadofaragene Firadenovec to Treat BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: Japan’s PMDA has accepted the NDA of nadofaragene firadenovec (intravesically; Q3W) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS ± papillary tumors (Ta/T1) NDA was backed by P-III study evaluating nadofaragene in 157 pts, where 5yr. follow-up data showed OS rate of 80% & a 49% cystectomy-free survival in adults with CIS…

ByRidhi RastogiSeptember 12, 2025

NEWS

Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The EMA has received MAA of icotrokinra (QD) for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO MAA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

ByRidhi RastogiSeptember 12, 2025

MAGAZINE

PharmaShots Magazine-September-2025 Edition

Medical psychedelics are a fascinating field that modern science has yet to comprehend completely. Researchers are still digging up, trying to find evidence-based outcomes to tap into a whole new opportunity in psychiatry and mental health medicines The September Edition unearths a brand-new perspective on psychedelics through engaging articles, illustrative infographics, trailing BioTrends, illuminating regulatory…

ByAditya SinghSeptember 11, 2025

NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment options MAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg)…

ByRidhi RastogiSeptember 11, 2025

NEWS

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Shots: The US FDA has accepted the BLA of Nanoecapsulated Sirolimus + Pegadricase (NASP; Q4W) for the treatment of uncontrolled gout (PDUFA: Jun 27, 2026) BLA was supported by P-III (DISSOLVE I & II) trials evaluating 2 NASP doses vs PBO in adults with uncontrolled gout, which met its 1EP of sustained decrease in serum…

ByRidhi RastogiSeptember 10, 2025

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

Biogen’s Zurzuvae Receives the EC’s Approval to Treat Severe Postpartum Depression

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Ferring Reports the PMDA’s NDA Acceptance of Nadofaragene Firadenovec to Treat BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Johnson & Johnson Reports the EMA’s MAA Submission of Icotrokinra to Treat Plaque Psoriasis (PsO)

PharmaShots Magazine-September-2025 Edition

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

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