(HealthDay)—The drug Xywav has been approved for expanded use in adults with a rare sleep disorder called idiopathic hypersomnia, the U.S. Food and Drug Administration…
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FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
Since the US Food and Drug Administration (FDA) established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised…
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FDA Approves Astepro Allergy
FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use WHIPPANY, N.J.–(BUSINESS WIRE) June 17, 2021– Bayer announced today that the U.S. Food and Drug…
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U.S. FDA declines to approve Avenue's IV formulation of non-opioid painkiller
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo(Reuters)…
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FDA, J&J near deal for COVID-19 vaccine production at Baltimore plant
Fox Business Flash top headlines for May 27 Check out what’s clicking on FoxBusiness.com. WASHINGTON—The Food and Drug Administration and vaccine maker Johnson & Johnson…
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FDA Approves Myfembree
FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE…
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This Is Why The FDA Hasn’t Authorized The COVID Vaccines
The first doses of the COVID-19 vaccine were administered back in December 2020, according to The Washington Post, but that was only under the emergency…
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South Africa Suspends J&J Vaccine Rollout After US Pause
JOHANNESBURG (Reuters) – South Africa has suspended the rollout of Johnson & Johnson’s (J&J) COVID-19 vaccine, its health minister said on Tuesday, after U.S. federal…
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FDA Lifts In-Person Dispensing Requirement for Mifepristone
The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy. In an April 12, 2021,…
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Will Psoriasis Patients Embrace Proactive Topical Therapy?
Long-term proactive topical management of plaque psoriasis with twice-weekly calcipotriene/betamethasone dipropionate foam has been shown in a high-quality randomized trial to be more effective than…
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