A clinical trial is evaluating the safety and tolerability of baricitinib in patients with Job syndrome who also have lupus-like disease or atopic dermatitis.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218900 by Saptalis Pharmaceuticals

The FDA has granted approval for ANDA218900, a generic version of Tofacitinib Citrate, submitted by Saptalis Pharmaceuticals.

RegulatoryJune 21, 2026

FDA Accepts Supplement for Lebrikizumab by Eli Lilly

The FDA has accepted the supplemental biologics application for Lebrikizumab (BLA761306) from Eli Lilly.

StrategyJune 21, 2026

NMR Reveals Key Excipient Interactions Affecting mAb Viscosity in Formulations

NMR spectroscopy identifies arginine and lysine as effective excipients that reduce mAb viscosity, while proline and glycine promote clustering.

ClinicalJune 21, 2026

Eli Lilly's Remternetug Study in Healthy Chinese Participants Initiated

Eli Lilly is conducting a safety and tolerability study of remternetug in healthy Chinese participants, lasting up to 25 weeks.

RegulatoryJune 20, 2026

FDA Accepts Supplement Application for IMULDOSA by Accord Biopharma

The FDA has accepted the supplemental application for IMULDOSA (USTEKINUMAB-SRLF) from Accord Biopharma.

RegulatoryJune 20, 2026

FDA Grants Priority Review for TZIELD (Teplizumab) Supplement

The FDA has granted priority review for the supplemental application of TZIELD (Teplizumab) by Provention Bio.

ClinicalJune 20, 2026

Study on Genetic Disorders of the Immune System Launched by NIAID

NIAID is conducting a study to evaluate individuals with specific immune system disorders, involving extensive genetic and medical assessments.

RegulatoryJune 19, 2026

FDA Grants AP Status for Methylprednisolone ANDA210985 by Ingenus Pharms

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for methylprednisolone submitted by Ingenus Pharms.

CompetitiveJune 19, 2026

Hikma's Methylprednisolone Sodium Succinate ANDA202691 Receives AP Status

Hikma's application for Methylprednisolone Sodium Succinate (ANDA202691) has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 18, 2026

FDA Accepts Supplement Application for SKYRIZI (Risankizumab)

The FDA has accepted a supplemental application for SKYRIZI, indicating ongoing development and potential label expansion.

RegulatoryJune 18, 2026

FDA Accepts Supplement Application for SKYRIZI (Risankizumab) by AbbVie

The FDA has accepted a supplemental application for SKYRIZI (Risankizumab) from AbbVie.

RegulatoryJune 18, 2026

Hikma's Methylprednisolone Sodium Succinate ANDA203125 Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Hikma's Methylprednisolone Sodium Succinate.

RegulatoryJune 17, 2026

FDA Accepts Roche's Gazyva for Systemic Lupus Erythematosus Treatment

The FDA has accepted Roche's sBLA for Gazyva/Gazyvaro, based on phase III ALLEGORY data showing significant efficacy in SLE.

RegulatoryJune 16, 2026

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

RegulatoryJune 8, 2026

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

The FDA has an active application (ANDA212634) for Mycophenolate Mofetil submitted by Strides Pharma, currently under standard review.

RegulatoryJune 8, 2026

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

The FDA has approved a supplemental application for Methylprednisolone Acetate submitted by Sandoz.

RegulatoryJune 8, 2026

Sandoz's Methylprednisolone ANDA040194 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status to Sandoz for methylprednisolone.

RegulatoryJune 6, 2026

FDA Approves Deflazacort Supplement Application by Upsher Smith Labs

The FDA has approved a supplemental application for Deflazacort submitted by Upsher Smith Labs.

Upcoming catalysts(1)

PDUFA Date

Regeneron — Dupixent

COPD label expansion would open multi-billion TAM beyond atopic indications.

June 27, 2026 · NDA/BLA

Indications

Autoimmune Disease →

Chronic obstructive pulmonary disease →

Genetic Disorders →

Type 1 Diabetes →

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