Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment

AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder

Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer

BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent

Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

Novo Nordisk's oral semaglutide gets EU approval for heart related treatment of type 2 diabet

EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke

Biocartis receives FDA approval for Idylla CDx MSI test

First fully automated, cartridge-based companion diagnostic test for colorectal cancer patients approved in the United States