After more than 10 hours of intense debate, a US Food and Drug Administration (FDA) advisory panel gave its support…
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FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma
PARIS, March 31, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with…
FDA Clears Device to Protect Kids Against Head Injury
The US Food and Drug Administration (FDA) has cleared a new over-the-counter device designed to protect children aged 13 years…
FDA review reveals J&J COVID-19 vaccine safe, effective
A single-shot COVID-19 vaccine made by Johnson & Johnson completely prevented hospitalizations and deaths in a large clinical trial, according…
Pfizer asks the FDA to let it store its Covid vaccine at warmer temps
Pfizer asks the FDA to let it store its coronavirus vaccine at warmer temperatures after study showed its shot can…
FDA Approves Libtayo (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Feb. 9, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S.…
FDA Approves Breyanzi
FDA Approves Breyanzi (lisocabtagene maraleucel) CAR-T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma PRINCETON, N.J.–(BUSINESS WIRE)…
FDA Approves Posimir
FDA Approves Posimir (bupivacaine) for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression CUPERTINO, Calif., Feb.…
Trump congratulates the FDA as it green lights Moderna's COVID vaccine
Trump congratulates the FDA as it green lights Moderna’s COVID-19 vaccine: US authorizes second shot in seven days and readies…
Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 30, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a…