FDA nod to YUVIWEL, first once-weekly treatment for kids with achondroplasia

Achondroplasia, a rare genetic disorder, causes skeletal dysplasia and often increases the risk of muscular, neurological, and cardiorespiratory complications

Caplin Steriles gets FDA approval for desmopressin

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease

Zydus receives final approvals from USFDA for Ivermectin Tablets USP

Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans

Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025

Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets

FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer

Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy

Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer

BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results

Merck Animal Health gets FDA nod for groundbreaking dog allergy drug NUMELVI

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder

Eugia Pharma receives USFDA Approval for Everolimus tablets