World of DTC Marketing

MARCH 18, 2021

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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Fierce Pharma

FEBRUARY 28, 2023

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

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World of DTC Marketing

JUNE 23, 2021

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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Fierce Pharma

MARCH 22, 2023

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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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.

Pharmacology

Fierce Pharma

FEBRUARY 17, 2023

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

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pharmaphorum

SEPTEMBER 28, 2022

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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Fierce Pharma

DECEMBER 29, 2022

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

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World of DTC Marketing

OCTOBER 21, 2021

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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Fierce Pharma

MARCH 7, 2023

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

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Fierce Pharma

OCTOBER 4, 2022

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

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MedCity News

MARCH 21, 2023

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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Fierce Pharma

MARCH 7, 2023

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

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World of DTC Marketing

JULY 13, 2021

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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Fierce Pharma

MARCH 10, 2023

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

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World of DTC Marketing

JUNE 17, 2021

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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Fierce Pharma

MARCH 13, 2023

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

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Fierce Pharma

MARCH 9, 2023

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

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MedCity News

MARCH 15, 2023

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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pharmaphorum

DECEMBER 19, 2022

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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Fierce Pharma

MARCH 20, 2023

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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Fierce Pharma

MARCH 16, 2023

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

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Fierce Pharma

NOVEMBER 29, 2022

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

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Fierce Pharma

JANUARY 18, 2023

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

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Fierce Pharma

JANUARY 31, 2023

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

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Fierce Pharma

NOVEMBER 30, 2022

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

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Fierce Pharma

FEBRUARY 23, 2023

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

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World of DTC Marketing

JUNE 24, 2021

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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Fierce Pharma

FEBRUARY 27, 2023

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

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Fierce Pharma

JANUARY 27, 2023

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

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Fierce Pharma

FEBRUARY 16, 2023

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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Fierce Pharma

MARCH 22, 2023

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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World of DTC Marketing

JUNE 8, 2021

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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Fierce Pharma

FEBRUARY 9, 2023

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

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MedCity News

JANUARY 25, 2023

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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MedCity News

FEBRUARY 17, 2023

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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Fierce Pharma

MARCH 2, 2023

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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MedCity News

FEBRUARY 26, 2023

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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Fierce Pharma

DECEMBER 12, 2022

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

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pharmaphorum

JULY 6, 2022

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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