Food And Drug Administration

The Fda Is Wrong To Pull Life-saving Covid-19 Antibody Treatments

The Food and Drug Administration suddenly decided to withdraw its emergency use authorization of two COVID-19 antibody treatments this week, leaving hundreds of patients who depend on them in the...

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This Is What Ron Desantis' Covid Fight With The Fda Is Really All About

The FDA has announced that two of the monoclonal antibody treatments that have been useful in treating COVID are not effective in treating the omicron variant, so the government is no longer going to be distributing those treatments. That sounds...

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Karyopharm's (kpti) Eltanexor Gets Orphan Drug Tag For Mds

Karyopharm Therapeutics Inc. KPTI announced that the FDA has granted Orphan Drug designation to its novel oral, selective inhibitor of nuclear export compound, eltanexor, for the treatment of myelodysplastic syndromes (“MDS”).The Orphan...

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Skyrizi Approved For Psoriatic Arthritis

WEDNESDAY, Jan. 26, 2022 -- The U.S. Food and Drug Administration has expanded the approval of Skyrizi (risankizumab-rzaa) to treatment of adults with active psoriatic arthritis, the manufacturer announced Friday. The dosing regimen of Skyrizi for...
Related topics: Psoriatic Arthritis, Arthritis

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Viking (vktx) Study On X-ald Put On Clinical Hold By The Fda

Viking Therapeutics, Inc. VKTX recently received a setback as the FDA placed a clinical hold on its early-stage study of pipeline candidate VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD).The regulatory body has requested an additional...
Related topics: Medical Research

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Pfizer Board Member Suggests End To Mask, Vaccine Mandates

Pfizer Board Member Suggests End To Mask, Vaccine Mandates Authored by Jack Phillips via The Epoch Times (emphasis ours), Dr. Scott Gottlieb, former director of the Food and Drug Administration (FDA) and current board member at Pfizer,...
Related topics: Pfizer, Vaccines

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Desantis Blasts Fda For Halting Drugs Ineffective On Omicron

The governor did not elaborate on how he plans to oppose to the decision from the FDA, which has sole authority over drug regulation in the US. Associated Press

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The Fda Rules Just Changed On Covid-10 Monoclonal Antibody Treatments

The U.S. Food and Drug Administration (FDA) has just released a new update in regards to the treatment options for COVID-19. As a result of the update, the FDA has removed the authorization for two monoclonal antibody treatments. Starting January...

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Ionis' (ions) Eplontersen Gets Orphan Drug Tag From Fda

Ionis Pharmaceuticals, Inc. IONS announced that the FDA has granted Orphan Drug designation to eplontersen, which is being developed for the treatment of transthyretin-mediated amyloidosis, a progressive and fatal condition.The Orphan Drug...

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Fda Limits Use Of Regeneron & Lilly's Covid Antibody Cocktails

The FDA announced that it has revised the emergency use authorization (EUA) for two cocktail antibody drugs — Eli Lilly’s LLY bamlanivimab plus etesevimab, and Regeneron Pharmaceuticals’ REGN REGEN-COV (casirivimab plus imdevimab)....

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"indefensible Edict" - Desantis Rages After Biden's Fda Restricts Use Of Monoclonal...

"Indefensible Edict" - DeSantis Rages After Biden's FDA Restricts Use Of Monoclonal Antibody Treatments Governor Ron DeSantis is demanding the Biden Administration reverse its sudden  decision to revoke emergency use authorization...
Related topics: Joe Biden

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Maybe A Hint Of Good News About Animal Antibiotics?

The FDA says use of medically important antimicrobial drugs in food animals decreased by 3% between 2019 and 2020  (For details, see the full report). Is this good news or not.  Use is down from 2015-2016, but up from 2017.  As Wired puts it,...
Related topics: Antibiotics

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5 Psychedelic Therapeutics Decisions Coming In 2022

Here is a look of a few of the biggest clinical trial and FDA updates in regards to psychedelics to watch for in 2022.
Related topics: Clinical Trials

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Us Drugs Watchdog Pulls Authorisation For Covid Monoclonal Antibodies

FDA says treatments from Regeneron and Eli Lilly ‘highly unlikely’ to work against Omicron strain

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Fda Wants More Info Before Approving Merck’s Chronic Cough Drug

Pharmaceutical company Merck has revealed that gefapixant, its experimental drug designed to address chronic cough, still has a ways to go before hitting the US market. As part of its announcement, Merck said it has received a Complete Response...
Related topics: Merck & Co, Cough

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Fda Expected To Restrict Use Of Two Covid-19 Monoclonal Antibody Treatments

The Food and Drug Administration is expected to significantly restrict the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron variant, a senior administration health official confirmed.As...

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Pfizer's (pfe), Opko's Bla For Somatrogon Gets Crl From Fda

Pfizer Inc. PFE, along with partner OPKO Health, Inc. OPK, announced that the FDA has issued a Complete Response Letter (“CRL”) to the biologics license application (“BLA”) for somatrogon for the treatment of growth hormone...
Related topics: Pfizer, Hormones

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What This Fda News Could Mean For Abbvie's Stock

Earlier this month, AbbVie (NYSE: ABBV) completed its application to the U.S. Food and Drug Administration (FDA) for Rinvoq to treat adults with a back arthritis (known as non-radiographic axial spondyloarthritis) who previously tried nonsteroidal...
Related topics: Arthritis

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Fda Approves Risankizumab (skyrizi) For Psoriatic Arthritis

The approval is the second indication for the anti-interleukin 23 monoclonal antibody after approval for plaque psoriasis was granted in 2019. News Alerts
Related topics: Psoriatic Arthritis, Arthritis, Psoriasis

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California Law Would Allow Kids 12 And Up To Get Vaccines Without Parents Permission

The law would cover any vaccine approved by the FDA. The post California Law Would Allow Kids 12 and Up to Get Vaccines Without Parents Permission first appeared on Le·gal In·sur·rec·tion.
Related topics: Vaccines

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