FDA Advisory Panel Says Yes to Pfizer’s COVID Vaccine
THURSDAY, Dec. 10, 2020 — A U.S. Food and Drug Administration advisory panel recommended on Thursday that the agency approve …
FDA Approves Eysuvis
FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease …
FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis
NEW YORK–(BUSINESS WIRE) October 27, 2020 — Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration …
FDA Approves First Ebola Virus Treatment
THURSDAY, Oct. 15, 2020 — The first drug for Zaire ebolavirus (Ebola virus) infection has been approved for adults and …
FDA approves new drug to treat common form of muscular dystrophy based on research from U of A scientist
A University of Alberta researcher’s past work has led to a new drug being approved for use in the United …
FDA Approves Detectnet
FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent Houston, TX and St. Louis, MO, Sept. …
New contraceptive approved by FDA, offers additional option for women
A first-of-its-kind contraceptive developed at the University of Illinois Chicago has been approved by the U.S. Food and Drug Administration. …
Merck receives FDA approval for Ebola vaccine
Merck licensing Ebola vaccine FBN’s Nicole Petallides on the outlook for Merck shares. The U.S. Food and Drug Administration said …
FDA approves $2M medicine, most expensive ever
U.S. regulators have approved the most expensive medicine ever, for a rare disorder that destroys a baby’s muscle control and …
Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
DUBLIN, March 18, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) …
Atossa Genetics Announces FDA Approval of Oral Endoxifen for “Expanded Access” as Post-Mastectomy Treatment for a U.S. Breast Cancer Patient
SEATTLE, March 14, 2019 (GLOBE NEWSWIRE) — Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and …
FDA chief Scott Gottlieb steps down after nearly 2 years
Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency’s response to a …
FDA Approves Herceptin Hylecta
South San Francisco, CA — February 28, 2019 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: …
FDA Approves Gloperba
WOBURN, Mass.–(BUSINESS WIRE)–February 26, 2019 ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical …
Don’t be fooled: thermography no substitute for mammograms, FDA says
(HealthDay)—Women should not be misled into thinking that thermography is an effective alternative to mammography for breast cancer screening, the …
FDA Approves First Customizable Insulin Pump
FRIDAY, Feb. 15, 2019 — The Tandem Diabetes Care t:Slim X2 insulin pump, which allows a patient to customize treatment, …
Apellis Pharmaceuticals’ APL-2 Receives Fast Track Designation from the FDA for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria
WALTHAM Mass., and CRESTWOOD, Ky., Feb. 11, 2019 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused …
FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
HORSHAM, Pa., Jan. 28, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food …