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Results For "prescription-drug"

102 News Found

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
Biotech | December 16, 2021

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria

ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Equipment shortage and overpriced APIs pinch the pharma industry
News | September 09, 2021

Equipment shortage and overpriced APIs pinch the pharma industry

A long waiting period for critical equipment and a 50% hike in the cost of APIs imported from China are among the immediate challenges


Dr Reddy’s launches Minoxidil for women
Drug Approval | September 07, 2021

Dr Reddy’s launches Minoxidil for women

It is the first-ever approval in India for the treatment of Female Pattern Hair Loss (FPHL) and will be available only on prescription by a dermatologist


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Vivera Pharmaceuticals gets US patent for ZICOH
Biotech | August 23, 2021

Vivera Pharmaceuticals gets US patent for ZICOH

The software enables real-time communication between patients, caregivers, physicians, and pharmacists and each cartridge in the device has a unique, traceable serial number registered to the patient


Pear Therapeutics’ three FDA authorised prescriptions available at OptumRx
Digitisation | August 11, 2021

Pear Therapeutics’ three FDA authorised prescriptions available at OptumRx

OptumRx to make Pear’s three commercial Prescription Digital Therapeutics accessible to patients with Optum formulary access.


Sun Pharma signs Cassiopea for license and supply agreements
News | July 27, 2021

Sun Pharma signs Cassiopea for license and supply agreements

Winlevi has been approved by the United States FDA as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older