Merck asks US FDA to authorize promising anti-COVID pill
Drugmaker Merck asked U.S. regulators Monday to authorize its pill against COVID-19 in what would add an entirely new and …
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FDA backs Pfizer COVID-19 boosters for seniors, high-risk
The U.S. moved a step closer Wednesday to offering booster doses of Pfizer’s COVID-19 vaccine to senior citizens and others …
U.S. FDA approves first biosimilar rival to Roche's blockbuster eye drug
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August …
U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenström’s Macroglobulinemia
CAMBRIDGE, Mass. & BEIJING, September 01, 2021–(BUSINESS WIRE)–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing …
U.S. FDA seeks new warnings on drugs from Pfizer, Lilly and AbbVie
FILE PHOTO: Syringe and vial are seen in front of displayed new Pfizer logo in this illustration taken, June 24, …
FDA Approves Twyneo
FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris NESS ZIONA, Israel, July 27, 2021 (GLOBE …
FDA to announce new warning for J&J vaccine after cases of rare autoimmune disorder
The Food and Drug Administration (FDA) is expected to announce a new warning for Johnson & Johnson’s COVID-19 vaccine, following …
FDA Approves Verkazia
FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis EMERYVILLE, Calif.–(BUSINESS WIRE) June 24, 2021 –Santen Inc., …
The FDA Has Good News On Vaccines For Parents Of Adolescents
It’s been a long 14 months for parents of preteens who are yet to be able to get vaccinated against …
FDA Approves Frontline Immunotherapy for Gastric Cancers
The US Food and Drug Administration (FDA) today approved the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb) in conjunction with certain chemotherapies …
FDA OKs first new ADHD drug in over a decade for children
U.S. regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity …
Adalimumab Earns FDA Approval for Ulcerative Colitis in Children
Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older …
COVID-19 Vaccines Were Rushed, but ‘All Steps Taken’
Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Yes, the vaccines already authorized for emergency use against …
FDA Approves Kineret (anakinra) for the Treatment of Deficiency of IL-1 Receptor Antagonist (DIRA)
WALTHAM, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) — Sobi™, an international biopharmaceutical company dedicated to rare diseases, announced that the …
FDA Approves Gemtesa
FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dec. …
US tops 17M coronavirus cases as FDA panel weighs Moderna COVID-19 vaccine
Fox News Flash top headlines for December 17 Fox News Flash top headlines are here. Check out what’s clicking on …
FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis
South San Francisco, CA — December 14, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: …
FDA Approves Emergency Use of Pfizer’s COVID-19 Vaccine
SATURDAY, Dec. 12, 2020 – The U.S. Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, …