INDIA – Dr. Reddy’s Laboratories has secured the U.S. Food and Drug Administration (USFDA) approval for its eye drops for post-surgery care, Difluprednate Ophthalmic Emulsion 0.05%. Following the regulatory approval,…
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FDA approves Merck’s Keytruda as adjuvant cancer treatment regardless of tumor’s PD-L1 expression levels
USA — The U.S. Food and Drug Administration (FDA) has cleared Merck & Co.’s immunotherapy Keytruda to treat early cases of lung cancer despite mixed results in the main study…
Read MoreFDA revokes authorization for AstraZeneca’s Covid antibody drug Evusheld citing ineffectiveness
USA — Evusheld, a preventative monoclonal antibody treatment for COVID-19, has lost its emergency use authorization in the United States because it is unlikely to be effective against the coronavirus…
Read MoreFDA approves Eli Lilly’s drug for advanced mantle cell lymphoma, to retail at US$21,000 per month
USA — The US Food and Drug Administration (FDA) has approved Eli Lilly and Co.’s drug (pirtobrutinib) for the treatment of a rare form of blood cancer. The indication aims…
Read MoreU.S., Switzerland sign pharmaceutical good manufacturing practices agreement
USA — The U.S. FDA has signed an agreement with Switzerland that will allow each country to rely on the “other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities, avoiding…
Read MoreSun Pharma unveils its novel injection for neonatal seizures in the US
INDIA – Sun Pharma has launched its phenobarbital sodium injection for the treatment of neonatal seizures, SEZABY, in the United States (US). The Mumbai-based multinational pharmaceutical company has expanded its…
Read MoreFDA details approach for finding optimal dosages for new cancer drugs
USA — The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical development and in it,…
Read MoreSun Pharma introduces novel anti-cancer drug, FDA issues warning letter to its Halol plant
INDIA – Sun Pharmaceutical Industries Limited (Sun Pharma) has expanded its product portfolio with the launch of its novel anti-cancer drug Palbociclib under brand name ” PALENOTM ” in India.…
Read MoreFDA approves Novo Nordisk’s diabetes pill as first-line therapy
USA — The US Food and Drug Administration (FDA) has approved a label update for Novo Nordisk’s oral semaglutide (Rybelsus) allowing the agent to be used as an initial treatment…
Read MoreDr. Reddy’s nabs trademark rights of high-quality breast cancer drug from Pfizer
INDIA – Dr. Reddy’s Laboratories Ltd. has acquired the domestic sale rights for breast cancer drug PRIMCYV® from Pfizer Products India Pvt Ltd. The trademark rights acquisition will build on…
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