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Clozapine Still Underused in Refractory Schizophrenia
2021-02-13 Mark Gualtieri Health News

With the exception of clozapine, the selection of an antipsychotic medication for acute treatment is driven by side effects. Dr Stephen Marder That’s a key

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U.S. FDA extends review period for Biogen's Alzheimer's drug to June
2021-01-29 Mark Gualtieri Health News

(Reuters) – Biogen Inc and partner Eisai Co Ltd said on Friday the U.S. Food and Drug Administration has extended the review period for their

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FDA Approves Lupkynis
2021-01-25 Mark Gualtieri Health News

FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis VICTORIA, British Columbia & ROCKVILLE, Md.– January 22, 2021 — Aurinia Pharmaceuticals Inc. today

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FDA approves 1st long-acting HIV drug combo, monthly shots
2021-01-22 Mark Gualtieri Health News

U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with

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Vertex Announces FDA Approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for Use in People With CF With Certain Rare Mutations
2021-01-17 Mark Gualtieri Health News

BOSTON–(BUSINESS WIRE)–December 21, 2020 — Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for Trikafta (elexacaftor/tezacaftor/ivacaftor

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FDA approves implant system for transfemoral amputations
2020-12-22 Mark Gualtieri Health News

(HealthDay)—The first implant system for transfemoral amputations was approved by the U.S. Food and Drug Administration, the agency announced Friday. The Osseoanchored Prostheses for the

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Amid evolving strains, COVID-19 vaccines likely need updates every 3 years, former FDA chief Gottlieb says
2020-12-21 Mark Gualtieri Health News

Siegel: ‘We should have 45 million people vaccinated by the spring’ Fox News medical contributor Dr. Marc Siegel reacts to Moderna vaccine beginning U.S. distribution.

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Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
2020-12-11 Mark Gualtieri Health News

Thursday, December 10, 2020 FDA expected to make a decision on Emergency Use Authorization in the coming days Positive vote based on totality of scientific

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FDA committee votes to OK Pfizer's coronavirus vaccine for EUA
2020-12-11 Mark Gualtieri Health News

Coronavirus vaccine meeting could be pandemic turning point New York Magazine claims the U.S. had a vaccine in the month of January; reaction and analysis

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Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers
2020-12-07 Mark Gualtieri Health News

South San Francisco, CA — December 1, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the

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