USA — Novo Nordisk’s Ozempic, a treatment for type 2 diabetes and off-label for weight loss, is no longer on the FDA’s drug shortage list after months of limited supply.…
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FDA advisory panel supports full approval of Pfizer’s COVID therapy
USA —Advisers to the U.S. Food and Drug Administration gave strong support for full approval of Pfizer’s oral antiviral COVID-19 treatment, Paxlovid, for adults at high risk of severe disease…
Read MorePfizer’s Zavzpret nasal spray granted FDA approval for migraine treatment
USA — The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. As the first…
Read MoreGlenmark, Cediprof ink distribution pact for prescription drugs in the US
INDIA – Glenmark Pharmaceuticals and Cediprof, Inc. have entered into an exclusive supply and distribution agreement for the latter’s prescription drugs in the United States. Glenmark’s current portfolio consists of…
Read MoreRevolutionary concussion detection blood test from Abbott receives FDA approval
USA— Abbott has received clearance from the U.S. Food and Drug Administration (FDA) for the first commercially available laboratory test for traumatic brain injury (TBI), which will be widely accessible…
Read MoreSun Pharma’s acquisition of Concert fuels hopes of deuruxolitinib push to FDA Drug Review
INDIA – Sun Pharma has wrapped up the acquisition of Concert Pharmaceuticals Inc. (Concert) with the desire to accelerate the market entry of deuruxolitinib, a potential best-in-class treatment for alopecia…
Read MoreFDA encourages adoption of continuous manufacturing to build a resilient pharma sector
USA — The FDA has issued final guidance on the use of continuous manufacturing in drug production, aimed at easing the industry’s transition to these advanced processes. The guidelines cover…
Read MoreFDA advisory panel to assess broader application of Merck-AstraZeneca cancer medication
USA —Merck & Co Inc and AstraZeneca have announced that an independent committee of advisers to the U.S. Food and Drug Administration (FDA) will evaluate their application for the expanded…
Read MoreFDA approves once-weekly hemophilia drug from Sobi and Sanofi
USA — The U.S. Food and Drug Administration (FDA) has granted approval for a new hemophilia treatment co-developed by Sanofi and Sobi that has the potential to offer greater convenience…
Read MoreU.S. and EU regulators to expedite reviews of Pfizer’s RSV vaccine
USA — Pfizer has announced that regulatory authorities in the US and Europe have accepted marketing applications for its RSVpreF vaccine candidate for respiratory syncytial virus (RSV), with decisions expected…
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