FDA – pharma.markets

Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation

21/03/2023 MaP 0

Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will offer US patients […]

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years

01/03/2023 MaP 0

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization […]

FDA grants priority review to Roche’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma

06/01/2023 MaP 0

Basel, 6 January 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s […]

Roche Alzheimer’s disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis

08/12/2022 MaP 0

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays have received […]

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

06/12/2022 MaP 0

PDF Version Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted an application to the U.S. Food and […]

25/10/2022 MaP 0

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval Following our communication last week “MedAlliance to be acquired by Cordis”, MedAlliance is pleased to make […]

Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU

05/10/2022 MaP 0

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. These patients with HER2 low status may now be eligible […]

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

22/08/2022 MaP 0

Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age […]

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY®

08/07/2022 MaP 0

… For Adolescents 12 through 15 Years of Age COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 […]

Pfizer and BioNTech Submit a Variation to EMA

08/07/2022 MaP 0

…. for the Vaccination of Children Ages 6 Months to less than 5 Years with COMIRNATY® Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: […]

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

17/06/2022 MaP 0

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety […]

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults

15/03/2022 MaP 0

Submission based on real-world safety and efficacy data from Israel Data showed rates of confirmed infections were 2 times lower and rates of severe illness […]

Bilateral trade in bivalve molluscan shellfish to resume between the U.S. and the EU

08/02/2022 MaP 0

The Office of the U.S. Trade Representative (USTR) announced on Friday, February 4, 2022, that the United States and the European Union (EU) have concluded […]

Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

01/02/2022 MaP 0

With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy […]

FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss

31/01/2022 MaP 0

Vabysmo (faricimab-svoa) targets and inhibits two disease pathways that drive neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME) Vabysmo is the […]