Asset / Drug

Regulatory Approval

Drug and asset intelligence for Regulatory Approval with 18 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 0
Catalysts: 18
Stage: Development stage unavailable

Sponsor company

Janssen Pharmaceuticals →

Recent signals

No signals indexed for this entity yet.

Upcoming milestones

No catalysts indexed for this entity yet.

Related catalysts(18)

Topline Data

GSK — Regulatory Approval

Monitor the timeline for final approval and any subsequent market launch plans.

June 21, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor for market entry timelines and any competitive responses from other hormone therapy manufacturers.

June 21, 2026 · N/A

Topline Data

Sun Pharma — Regulatory Approval

Monitor the timeline for final approval and market entry, as well as competitor responses.

June 20, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor the uptake of the CNPV program by companies and any resulting changes in approval timelines for new drugs.

June 19, 2026 · N/A

Topline Data

Impax Labs — Regulatory Approval

Monitor market uptake and prescriber adoption rates, as well as any emerging safety data.

June 19, 2026 · N/A

Topline Data

Roche — Regulatory Approval

Monitor the FDA's decision on giredestrant's approval by November 30, 2026, and ongoing results from the lidERA study regarding overall survival data.

June 16, 2026 · N/A

Topline Data

Roche — Regulatory Approval

Monitor the FDA's decision on giredestrant by November 30, 2026, and further clinical data on overall survival.

June 16, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor uptake in pediatric patients and any competitive responses from other diabetes treatments.

June 16, 2026 · N/A

Topline Data

AstraZeneca — Regulatory Approval

Monitor any follow-up actions from AstraZeneca regarding further data submissions or trial results to address ODAC concerns.

June 16, 2026 · N/A

Topline Data

Lilly — Regulatory Approval

Monitor market uptake of EBGLYSS and competitor responses, particularly from companies with existing atopic dermatitis therapies.

June 16, 2026 · N/A

Topline Data

AstraZeneca — Regulatory Approval

Monitor the new PDUFA date and any updates on the additional data requested by the FDA.

June 16, 2026 · N/A

Topline Data

— Regulatory Approval

Results from the ongoing efficacy trials and any subsequent market responses or competitor developments in OUD treatment.

June 11, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor the FDA's final decision on the application and any subsequent market entry timelines from Strides Pharma.

June 8, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor for the final approval and market entry date, as well as any competitive responses from other manufacturers.

June 8, 2026 · N/A

Topline Data

Janssen Pharmaceuticals — Regulatory Approval

Monitor for market entry timelines and any competitive responses from other antiepileptic drug manufacturers.

June 6, 2026 · N/A

Topline Data

AstraZeneca — Regulatory Approval

Monitor post-approval market uptake, physician adoption rates, and any competitive responses from other hypertension therapies.

June 1, 2026 · N/A

Topline Data

AstraZeneca — Regulatory Approval

Monitor market uptake and physician adoption rates, as well as any competitive responses from other asthma therapies.

June 1, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor how companies adjust their safety study protocols and any resulting changes in drug labeling or approval processes.

June 1, 2026 · N/A

Indications

No related entities indexed yet.

Therapeutic areas

Addiction Medicine · Opioid Use Disorder →

Cardiology · Hypertension →

Dermatology · Atopic Dermatitis →

Endocrinology · Hormone Replacement Therapy →

Endocrinology · Type 1 Diabetes →

General · Drug Development →

General · Drug Safety →

Immunology · Corticosteroid →

Immunology · Immunosuppressant →

Infectious Disease · Antibiotic →

Infectious Disease · Antimalarial →

Neurology · Antiepileptic →

Neurology · Cough Suppressant →

Oncology · Breast Cancer →

Oncology · Hormone Receptor-positive Breast Cancer →

Respiratory · Asthma →

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