GE HealthCare announced that View has received 510(k) clearance from the FDA. Designed as a fast, diagnostic, zero‑footprint viewer, View serves as the core anchor of the Genesis… read more.
Ardelyx Inc. announced the publication of data from its IBS-C clinical development program, “Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis”… read more.
Tenpoint Therapeutics, Ltd., announced that the FDA approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, the first and only dual-agent eye drop… read more.
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.
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.
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.
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