Zydus has received a final nod from the US’s drug regulator to market Dapagliflozin Tablets.
Sanofi, GlaxoSmithKline to seek
authorisation for Covid vaccine
Drug majors Sanofi and GlaxoSmithKline will seek drug regulator approval for a new Covid vaccine after clinical trials showed promising results.
Rinvoq Wins FDA Approval
Rinvoq is used to treat patients above 12 with moderate-to-severe atopic dermatitis who do not respond to or cannot take other systemic medications.
FDA Okays Pembrolizumab CDx for
MSI-H Solid Tumors
The FDA has okayed FoundationOne CDx as a companion diagnostic to pembrolizumab for patients suffering from microsatellite instability-high solid tumours.
Nalmefene HCl Injection Receives a Green
Signal from FDA
Purdue Pharma’s Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects.
DORAs Gets FDA Clerance
Dual orexin receptor antagonists act by blocking signals in the brain that stimulate wakefulness.
Teleflex Gets FDA Approval for
Expanded Indication for Specialty
Catheter and Coronary Guidewire Use
in CTO PCI Procedures
Around 57000 chronic total occlusion interventions are performed annually in the USA.
MilliporeSigma Acquires Exelead
The acquisition cost is around USD 780 mn in cash.
Bluezone Model 450 Air Cleaner Wins
FDA 510(k) Class II Medical Device
Approval
The Bluezone Model 450 Air Purifier is a device for the inactivation of viral aerosols in medical facilities and occupied spaces.
APNAR Pharma buys Aurex Labs
The business deal includes around 68000 sq. ft. manufacturing plant in New Jersey, USA.