Drug Approval | August 20, 2022
Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Therapy recently approved in Canada under the brand name KORSUVA
Therapy recently approved in Canada under the brand name KORSUVA
This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The card-to-cloud device was launched into the U.S. and many other markets and is designed to work without an embedded communications module.
The Trial, the first of its kind in Israel, recently obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.
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