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Ocugen to apply for full US FDA approval of Covaxin, not for EUA expresspharma
June 15, 2021
Ocugen said the decision was based on a recommendation from the US FDA, which also requested more information and data for full approval.
Spinogenix Granted FDA Orphan Drug Designation for SPG302 for the Treatment of Amyotrophic Lateral Sclerosis americanpharmaceuticalreview
June 09, 2021
Spinogenix, Inc. announced it has been granted Orphan Drug Designation (ODD) for SPG302 in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) by the U.S. FDA.
FDA Approves Drug to Treat Smallpox americanpharmaceuticalreview
June 09, 2021
The U.S. FDA approved Tembexa (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus ...
FDA Authorizes Lower Intravenous and Subcutaneous Dose of REGEN-COV™ Antibody Cocktail to Treat Patients with COVID-19 americanpharmaceuticalreview
June 09, 2021
Regeneron Pharmaceuticals Inc. announced the U.S. FDA updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized.
Biogen gets US FDA accelerated approval for Aduhelm to treat Alzheimer’s expresspharma
June 09, 2021
It is the first new treatment approved for Alzheimer's since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.
FDA Approves Aducanumab To Treat Alzheimer’s Disease contractpharma
June 09, 2021
The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003.
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA americanpharmaceuticalreview
June 08, 2021
Ortho Regenerative Technologies Inc, a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, announced that it has received a clinical hold letter from the U.S. FDA related to its ...
Lupin gets USFDA nod to market generic HIV drug expresspharma
June 08, 2021
The company has received approval from the United States Food and Drug Administration (USFDA) to market its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, Lupin said in a regulatory filing.
Fake Covid-19 Vaccines Pose New Threat in Africa firstwordpharma
June 07, 2021
Counterfeit COVID-19 vaccines are posing a new threat in Africa, as reported Morningstar on Sunday.
Full FDA approval could drive COVID-19 vaccinations, but experts advise against waiting firstwordpharma
June 07, 2021
According to the Kaiser Family Foundation's latest vaccine monitor report, 32% of adults in the US unvaccinated for COVID-19 are waiting for full FDA approval of a vaccine before getting it, ABC News reported on Sunday.

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