Frontiers23d
Population pharmacokinetic analysis and dosing regimen optimization of teicoplanin in critically ill patients with sepsis
Teicoplanin PPK modeling was conducted using the non-linear mixed-effect modeling approach by NONMEM software (version 7.4, ICON Development Solutions ... areas represent the 95% CI of medians, and ...
Business Insider27d
Novartis announces CHMP of EMA adopted positive opinion for Fabhalta
EMA, has adopted a positive opinion and recommended granting a marketing authorization for Fabhalta – a first-in-class oral Factor B inhibitor of the alternative complement pathway – for the ...
Yahoo Finance13d
Unsafe and unregulated cell therapies being sold in Europe
Whilst the EMA has approved multiple products for patient use, the agency said that individuals, companies, and clinics are also marketing unregulated ATMPs. There is little to no evidence these ...
Business Insider27d
Biogen, Eisai announces CHMP of EMA reaffirmed positive opinion of lecanemab
Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has reaffirmed its positive opinion by consensus for ...
Pharmabiz23d
EMA committee recommends approval of AstraZeneca’s Imfinzi in combo with chemotherapy to treat resectable non-small cell lung cancer
AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU ... of the European Medicines Agency (EMA) based its positive opinion on ...
Yahoo Finance4d
Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol
Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. Piclidenoson is a novel ...
Teen Vogue11d
Blue Ivy Carter Gave This Controversial Cool Girl Trend Her Stamp of Approval
Blue Ivy Carter just gave the controversial cool girl trend her stamp of approval, and yes, we are talking about wearing sunglasses at night. Over the weekend, Blue Ivy was spotted attending the ...
The Globe and Mail7d
Traumatic Brain Injury Drug Market 2034: Clinical Trials, EMA, PDMA, FDA Approval, Medication, Epidemiology, Therapies and Companies by DelveInsight
Traumatic Brain Injury companies include Supernus Pharmaceuticals, Inc., Hope Biosciences, The SanBio Group, Merz Pharmaceuticals GmbH, Cellvation, Inc., Abalonex ...
Nasdaq27d
Krystal Biotech, Inc. Welcomes Positive EMA Recommendation for VYJUVEK® Approval in Dystrophic Epidermolysis Bullosa
If approved, VYJUVEK will be marketed in Europe as a simple, effective therapy for patients from birth. The European Commission's final decision on VYJUVEK is anticipated in the second quarter of ...
MedPage Today14d
Approved Sickle Cell Drug Fails to Beat Placebo in Trial
SUSTAIN was the basis for FDA approval and European Medicines Agency (EMA) approval for crizanlizumab for the prevention of vaso-occlusive crises in patients ages 16 years and older with sickle ...
CNN10d
History-making Blue Ghost lunar lander sends one last message from the moon
Sign up for CNN’s Wonder Theory science newsletter. Explore the universe with news on fascinating discoveries, scientific advancements and more. Firefly Aerospace ...
CNN26d
Firefly’s Blue Ghost lander successfully touches down on the moon
Firefly’s 6.6-foot-tall (2-meter-tall) Blue Ghost lunar lander touched down on the moon’s near side around 2:34 a.m. CT (3:34 a.m. ET) Sunday. A parade of lunar landers developed by the ...