Pfizer Inc. announced the FDA has granted full approval to Braftovi (encorafenib) in combination with cetuximab (Erbitux ) and fluorouracil-based chemotherapy for the treatment of adult patients with… read more.
The EMA has recommended the refusal of the marketing authorisation for Daybue, intended for the treatment of Rett syndrome, a rare inherited condition that affects the brain and… read more.
The EMA has recommended the refusal of the marketing authorisation for Iloperidone Vanda Pharmaceuticals, a medicine intended for the treatment of schizophrenia and manic or mixed episodes associated… read more.
BD (Becton, Dickinson and Company) announced it has obtained CE Marking for the Revello Vascular Covered Stent, a next-generation endovascular solution for the treatment of atherosclerotic lesions in… read more.
Medtronic announced that the first U.S. commercial surgical case using its recently FDA-cleared Hugo robotic-assisted surgery (RAS) system has been successfully performed by Jihad Kaouk, MD, professor and… read more.
Hansa Biopharma AB announced that its Biologics License Application (BLA) for imlifidase has been accepted by the FDA. The FDA’s filing review was completed on day 60 which… read more.
NICE(UK): Cerliponase alfa is not recommended, within its marketing authorisation, for treating neuronal ceroid lipofuscinosis type 2 (CLN2; also known as tripeptidyl peptidase 1 deficiency). This recommendation is not intended… read more.
Intellia Therapeutics Presents Longer-Term Clinical Data for Lonvoguran Ziclumeran (lonvo-z); Hereditary Angioedema (HAE) Patient-Focused Research at AAAAI 2026. Presentations include three-year follow-up data from patients receiving a one-time… read more.
Eli Lilly and Company announced the FDA approved a label expansion for Zepbound (tirzepatide) to include the four-dose single-patient use KwikPen that delivers a full month of treatment… read more.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Jazz Pharmaceuticals Research UK Limited for zanidatamab (Ziihera) in adults to treat biliary tract cancer whose cancer… read more.
The EMA’s CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Kayshild (semaglutide), intended for the treatment of adults with non-cirrhotic metabolic dysfunction-associated… read more.
Pfizer Inc. announced positive topline progression-free (PFS) survival results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi (encorafenib) in combination with cetuximab… read more.
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