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Results For "authorization"

327 News Found

Briefs: Relonchem, Patel Chem Specialities and J & H Pharma Consultants
News | September 24, 2025

Briefs: Relonchem, Patel Chem Specialities and J & H Pharma Consultants

Relonchem receives marketing authorization for Moxonidine tablets


Shukra Pharmaceuticals inks distribution tie-up with Wockhardt
Supply Chain | September 12, 2025

Shukra Pharmaceuticals inks distribution tie-up with Wockhardt

The products include high-quality, advanced anti-infective formulations such as EMROK (Levonadifloxacin) and MIQNAF (Nafithromycin)


Gilead’s Yeytuo approved in EU for HIV prevention
Drug Approval | August 28, 2025

Gilead’s Yeytuo approved in EU for HIV prevention

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option


European Commission grants approval of Ogsiveo
News | August 18, 2025

European Commission grants approval of Ogsiveo

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors


Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr
News | August 13, 2025

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease


Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
Drug Approval | July 11, 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials


Bayer submits EU application for Gadoquatrane MRI contrast agent
News | July 11, 2025

Bayer submits EU application for Gadoquatrane MRI contrast agent

It is intended for contrast enhancement in MRI scans