Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12%

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial

PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy

Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

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

Indoco Remedies bags USFDA nod for Lacosamide oral solution

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa