Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia

USFDA approves intramuscular administration for Merck’s MMRV family of vaccines

With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly

Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)

Eye-Q inaugurates its new facility in Yamunanagar

The new facility will be able to handle four times as many patients as the previous facility.

Lupin signs distribution agreement with Medis for Orphan Drug NaMuscla@

NDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following voluntary contraction

Fortis launches 4 specialized clinics in Bengaluru to tackle under-discussed health issues

The new facilities are designed to provide focused, patient-centric care through advanced diagnostics, minimally invasive treatments, and multidisciplinary expertise

Asahi Kasei Pharma & Alchemedicine launch first human trials for hard-to-treat diseases drugs

HanchorBio scores first FDA orphan drug tag for gastric cancer therapy

The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients