Caplin Steriles gets USFDA approval

The injection comes in multiple formats

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.

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases

Yugap Wellness bolsters scientific leadership with Dr Satish Singh appointment

A PhD in Pharmaceutical Sciences, Dr Singh has led global regulatory audits, product validations, and quality systems spanning therapeutic formulations, dietary supplements, and functional foods

FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'

VETMEDIN (pimobendan) chewable tablets and VETMEDIN solution (pimobendan oral solution) can delay the onset of congestive heart failure (CHF) in dogs