Regulatory

Synopsis: The U.S. Food and Drug Administration has approved Agios Pharmaceuticals’ candidate treatment for a rare type of hemolytic anemia. The regulator…

In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance which had never been authorised…

Summary : SOLOSEC® demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on a landmark Phase 3…

Synopsis : Star Therapeutics has exited stealth mode and announced a spin-off company, Electra Therapeutics. Electra received $84 million in Series B…

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…

Summary: Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug…

MINUTES OF THE 436th REGISTRATION COMMITTEE MEETING HELD ON 28.01.2022 The 436th meeting of the Registration Committee (RC) was held under the…

Summary : The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates…

It is not uncommon for different countries to require at least part of a clinical trial be conducted in their country. The…

Synopsis: The U.S. Food and Drug Administration announced it is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib). The drug…