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Dear FDA: WTF?

World of DTC Marketing

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. The FDA’s scientists don’t understand marketing because marketing is not a science.

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FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

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The FDA and Aduhelm: WTF?

World of DTC Marketing

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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Apellis wins FDA approval for first geographic atrophy drug

Fierce Pharma

Apellis wins FDA approval for first geographic atrophy drug fkansteiner Fri, 02/17/2023 - 18:06

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. .

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Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

Fierce Pharma

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42

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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 FDA Accelerated Approval

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FDA delays BioMarin's gene therapy approval decision by 3 months

Fierce Pharma

FDA delays BioMarin's gene therapy approval decision by 3 months zbecker Tue, 03/07/2023 - 10:41

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AstraZeneca's Evusheld loses potency against new omicron subvariant, FDA warns

Fierce Pharma

AstraZeneca's Evusheld loses potency against new omicron subvariant, FDA warns. kdunleavy. Tue, 10/04/2022 - 10:37

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FDA Warning Letter Issued to Website Purveying Ivermectin Pills for Covid-19

MedCity News

The FDA has issued a warning letter to a website that has been selling the antiparasitic drug ivermectin as a treatment for Covid-19. BioPharma Daily Legal Pharma SYN Top Story biopharma nl FDA FDA Warning Letter ivermectin Merck Stromectal

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Will the FDA investigate GSK over Zantac? DeLauro wants to know

Fierce Pharma

Will the FDA investigate GSK over Zantac? DeLauro wants to know kdunleavy Tue, 03/07/2023 - 14:54

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Drug companies know how to play the FDA drug approval process

World of DTC Marketing

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.

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FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva

Fierce Pharma

FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva aliu Fri, 03/10/2023 - 10:49

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“I don’t trust the FDA anymore”

World of DTC Marketing

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.

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Acadia's Daybue wins FDA nod as first treatment for Rett syndrome

Fierce Pharma

Acadia's Daybue wins FDA nod as first treatment for Rett syndrome esagonowsky Mon, 03/13/2023 - 09:28

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Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy

Fierce Pharma

Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy aliu Thu, 03/09/2023 - 17:22

FDA 264
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FDA Clears TytoCare’s New Algorithm for Wheeze Detection

MedCity News

Virtual care company TytoCare has received FDA clearance for its wheeze detection algorithm, allowing the company to begin commercializing the product in the U.S. Daily Health Tech SYN Top Story algorithm artificial intelligence at home care FDA Clearance primary care telehealth TytoCare

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FDA approves Adstiladrin as first gene therapy for NMIBC

pharmaphorum

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “This approval provides healthcare professionals with an innovative treatment option for [these] patients.”. The post FDA approves Adstiladrin as first gene therapy for NMIBC appeared first on.

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AAD: Awaiting FDA decision in psoriasis, UCB touts 48-week data for bimekizumab in hidradenitis suppurativa

Fierce Pharma

AAD: Awaiting FDA decision in psoriasis, UCB touts 48-week data for bimekizumab in hidradenitis suppurativa zbecker Mon, 03/20/2023 - 11:19

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Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee

Fierce Pharma

Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee kdunleavy Thu, 03/16/2023 - 16:46

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Roche pulls another FDA accelerated approval for cancer drug Tecentriq

Fierce Pharma

Roche pulls another FDA accelerated approval for cancer drug Tecentriq. kdunleavy. Tue, 11/29/2022 - 10:22

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FDA fires back at conservative group's lawsuit over abortion pill approval

Fierce Pharma

FDA fires back at conservative group's lawsuit over abortion pill approval. zbecker. Wed, 01/18/2023 - 11:30

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In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion

Fierce Pharma

In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion aliu Tue, 01/31/2023 - 10:37

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Argenx hands bluebird $102M for FDA speedy review voucher

Fierce Pharma

Argenx hands bluebird $102M for FDA speedy review voucher. fkansteiner. Wed, 11/30/2022 - 09:34

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Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio

Fierce Pharma

Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio zbecker Thu, 02/23/2023 - 15:45

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Another reason change is needed at FDA? Fair balance

World of DTC Marketing

If the FDA understood consumer behavior like marketers instead of scientists, they would understand how DTC works. More importantly, the FDA needs to work with online sites to eliminate health misinformation. This is normal, and the FDA should take note.

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After FDA snub, Akebia's oral anemia drug Vafseo nears EU nod

Fierce Pharma

After FDA snub, Akebia's oral anemia drug Vafseo nears EU nod zbecker Mon, 02/27/2023 - 15:51

FDA 219
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With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug

Fierce Pharma

With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug aliu Fri, 01/27/2023 - 15:29

FDA 279
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Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod

Fierce Pharma

Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod fkansteiner Thu, 02/16/2023 - 14:12

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In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type

Fierce Pharma

In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type zbecker Wed, 03/22/2023 - 17:30

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A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers.

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Regeneron wins another FDA nod for powerhouse Eylea despite trial flops

Fierce Pharma

Regeneron wins another FDA nod for powerhouse Eylea despite trial flops kdunleavy Thu, 02/09/2023 - 10:30

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How Will FDA Guidance Impact Decentralized Clinical Trials in 2023?

MedCity News

The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion.

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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

FDA approval of the Chiesi drug comes about five years after European regulators authorized the product. BioPharma Daily Legal Pharma SYN Top Story biopharma nl Boston Chiesi Farmaceutici Clinical Trials FDA Italy rare diseases

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With 2nd chance at FDA approval, BioMarin preps for hemophilia gene therapy launch in US

Fierce Pharma

With 2nd chance at FDA approval, BioMarin preps for hemophilia gene therapy launch in US zbecker Thu, 03/02/2023 - 16:28

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FDA Authorizes First Covid-19 and Flu Test, But Its Maker Files for Bankruptcy

MedCity News

Lucira Health now has the first FDA authorized diagnostic that detects the novel coronavirus and influenza in a single test. BioPharma Daily Devices & Diagnostics Legal SYN Top Story bankruptcy biopharma nl California Clinical Trials COVID-19 Diagnostics Emeryville FDA Lucira Health

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Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati

Fierce Pharma

Mirati kicks off KRAS showdown with FDA approval for Krazati. Watch out, Amgen. Mon, 12/12/2022 - 18:14

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FDA backs pharmacist prescribing of Paxlovid for COVID

pharmaphorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The FDA’s amendment to the EUA comes as Pfizer has just filed for full approval of Paxlovid.

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