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1151 News Found

Dr Reddy’s receives Emergency Use Authorisation for molnupiravir
Drug Approval | December 28, 2021

Dr Reddy’s receives Emergency Use Authorisation for molnupiravir

The company will market it under the brand name Molflu


Optimus Pharma to manufacture and market molnupiravir
Drug Approval | December 28, 2021

Optimus Pharma to manufacture and market molnupiravir

The company has developed the API in house at its R&D center in Hyderabad


Merck acquires Chord Therapeutics to expand its neuroinflammatory pipeline
News | December 22, 2021

Merck acquires Chord Therapeutics to expand its neuroinflammatory pipeline

Acquisition provides opportunity to develop cladribine in generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD)


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


U.S. FDA approves first and only injectable option for HIV prevention
Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition


Shilpa Medicare launch Prucalshil for treatment of constipation
Drug Approval | December 21, 2021

Shilpa Medicare launch Prucalshil for treatment of constipation

Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


Sun gets US FDA approval for generic amphotericin B injection
Drug Approval | December 16, 2021

Sun gets US FDA approval for generic amphotericin B injection

It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity


Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug
Drug Approval | December 11, 2021

Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug

The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.