Summary : After a long wait, Bharat Biotech’s Covaxin has finally got the nod from the US Food and Drug Administration (USFDA)…
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Synopsis: The U.S. Food and Drug Administration has approved Agios Pharmaceuticals’ candidate treatment for a rare type of hemolytic anemia. The regulator…
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Summary : SOLOSEC® demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on a landmark Phase 3…
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Synopsis : Star Therapeutics has exited stealth mode and announced a spin-off company, Electra Therapeutics. Electra received $84 million in Series B…
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Summary : The U.S. Food and Drug Administration has accepted Mirati Therapeutics’ New Drug Application (NDA) for its candidate drug for non-small cell lung cancer (NSCLC). The…
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RegulatoryU.S FDA
Zydus Pharmaceuticals (USA) Inc gets final US FDA approval to market Roflumilast tablets
by adminby adminSummary: Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug…
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CompaniesEli LillyRegulatoryU.S FDA
Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19
by adminby adminSummary : The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates…
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It is not uncommon for different countries to require at least part of a clinical trial be conducted in their country. The…
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RegulatoryU.S FDA
FDA Investigating Possible Death Risk Linked to TG Therapeutics’ Lymphoma Drug
by adminby adminSynopsis: The U.S. Food and Drug Administration announced it is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib). The drug…
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Summary : The U.S. Food and Drug Administration approved Sanofi’s proposed drug to address red blood cell destruction in patients living with…