Zydus Cadila announces USFDA approval for Ibrutinib capsules

Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.

Zydus Cadila receives final approval from USFDA for Droxidopa capsules

It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited

Dr. Reddy's launches novel drug for chronic constipation management

Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB

Tonix receives FDA approval of Tonmya for treatment of fibromyalgia

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo