2023 and FDA - Pharma Rep Focus

How Will FDA Guidance Impact Decentralized Clinical Trials in 2023?

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. The agency’s goal is to spur a macro shift in clinical trials.

FDA

FDA Biopharma

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Fierce Pharma

APRIL 19, 2023

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

FDA

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

MAY 19, 2023

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

FDA

Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions

MedCity News

JANUARY 5, 2023

Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.

FDA

FDA Biopharma Pharma

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

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

A recent draft from the FDA provides valuable insight. Explore the limitations of what we know about prescription drug dosing The future of Clinical Research April 12, 2023 at 11:00 am PDT, 2:00 pm EDT, 7:00 pm GMT What will the future hold for clinical research?

FDA

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

Fierce Pharma

FEBRUARY 28, 2023

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

FDA

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line

Fierce Pharma

DECEMBER 18, 2022

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line. Sun, 12/18/2022 - 17:18.

Pharma

Pharma FDA

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

MAY 31, 2023

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

FDA

FDA Patients

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo

Fierce Pharma

MAY 19, 2023

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39

FDA

FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

MedCity News

APRIL 13, 2023

Rejection of Eli Lilly’s mirikizumab means that two of the four drugs the pharma giant identified as revenue growth drivers for 2023 have failed to pass the regulatory bar. One of those drugs has been approved while the fourth drug still awaits an FDA decision.

FDA

FDA Manufacturing Pharma Biopharma

Apellis wins FDA approval for first geographic atrophy drug

Fierce Pharma

FEBRUARY 17, 2023

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

FDA

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

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

FDA

Eli Lilly slapped with third FDA rejection in 2023, this time for eczema treatment lebrikizumab

Fierce Pharma

OCTOBER 2, 2023

After laying out a goal to launch four new drugs in 2023, Eli Lilly has run into yet another regulatory snag. | The FDA has rejected Lilly’s investigational atopic dermatitis treatment lebrikizumab over findings uncovered during the inspection of a third-party contract manufacturing organization.

FDA

FDA Manufacturing

FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time

Fierce Pharma

APRIL 25, 2023

FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time aliu Tue, 04/25/2023 - 14:16

FDA

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

Fierce Pharma

MAY 19, 2023

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21

FDA

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

MAY 22, 2023

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

FDA

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

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

FDA

First FDA Approval of an RSV Vaccine Goes to GSK

MedCity News

MAY 3, 2023

FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.

FDA

FDA Biopharma Pharma

FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

Fierce Pharma

APRIL 26, 2023

FDA approves first oral microbiome therapy Vowst. aliu Wed, 04/26/2023 - 11:30 Will Nestlé be around to help Seres with the launch?

FDA

Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Fierce Pharma

SEPTEMBER 19, 2023

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality (..)

FDA

FDA Manufacturing Pharma

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid

Fierce Pharma

MAY 19, 2023

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30

FDA

AstraZeneca, Sanofi tee up 3-way RSV battle in 2023 as FDA signals expedited review for antibody

Fierce Pharma

JANUARY 5, 2023

AstraZeneca, Sanofi tee up 3-way RSV battle in 2023 as FDA signals expedited review for antibody. Thu, 01/05/2023 - 10:13.

FDA

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

Fierce Pharma

JANUARY 31, 2023

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

FDA

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy

Fierce Pharma

MAY 1, 2023

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35

FDA

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

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

FDA

AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease

Fierce Pharma

MAY 18, 2023

AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease kdunleavy Thu, 05/18/2023 - 15:54

FDA

After FDA rejection, Gilead's Hepcludex looks set for full EU nod

Fierce Pharma

MAY 5, 2023

After FDA rejection, Gilead's Hepcludex looks set for full EU nod kdunleavy Fri, 05/05/2023 - 09:45

FDA

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

Fierce Pharma

MARCH 7, 2023

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

FDA

FDA advisers back Lundbeck and Otsuka's Rexulti in Alzheimer's disease agitation

Fierce Pharma

APRIL 14, 2023

FDA advisers back Lundbeck and Otsuka's Rexulti in Alzheimer's disease agitation zbecker Fri, 04/14/2023 - 18:14

FDA

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

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

FDA

Is the first NASH drug approval nearing? Intercept stages comeback as FDA sets decision date

Fierce Pharma

JANUARY 19, 2023

Intercept stages comeback as FDA sets decision date aliu Thu, 01/19/2023 - 11:06 Is the first NASH drug approval nearing?

FDA

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

Fierce Pharma

MAY 17, 2023

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41

FDA

FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss

Fierce Pharma

APRIL 4, 2023

FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss aliu Tue, 04/04/2023 - 16:48

FDA

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

Fierce Pharma

FEBRUARY 23, 2023

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

FDA

AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use

Fierce Pharma

JANUARY 11, 2023

AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use. Wed, 01/11/2023 - 09:03. esagonowsky.

FDA

Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro

Fierce Pharma

MAY 24, 2023

Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro kdunleavy Wed, 05/24/2023 - 09:46

FDA

Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

Fierce Pharma

SEPTEMBER 12, 2023

Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday.

FDA

FDA Pharma

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

MAY 17, 2023

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

Safety

Safety FDA

ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Fierce Pharma

DECEMBER 11, 2023

ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy aliu Mon, 12/11/2023 - 14:51

FDA

FDA clears Braeburn's long-acting Braxadi to treat opioid use disorder

Fierce Pharma

MAY 24, 2023

FDA clears Braeburn's long-acting Braxadi to treat opioid use disorder zbecker Wed, 05/24/2023 - 09:15

FDA

Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion

Fierce Pharma

MAY 9, 2023

Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion zbecker Tue, 05/09/2023 - 10:51

FDA

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

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

FDA

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

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

FDA

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

Fierce Pharma

MARCH 13, 2023

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

FDA

How Will FDA Guidance Impact Decentralized Clinical Trials in 2023?

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Trending Sources

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions

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

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

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo

FDA Rejects Eli Lilly Ulcerative Colitis Drug Over Manufacturing Issues

Apellis wins FDA approval for first geographic atrophy drug

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

Eli Lilly slapped with third FDA rejection in 2023, this time for eczema treatment lebrikizumab

FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

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

First FDA Approval of an RSV Vaccine Goes to GSK

FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid

AstraZeneca, Sanofi tee up 3-way RSV battle in 2023 as FDA signals expedited review for antibody

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

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy

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

AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease

After FDA rejection, Gilead's Hepcludex looks set for full EU nod

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

FDA advisers back Lundbeck and Otsuka's Rexulti in Alzheimer's disease agitation

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

Is the first NASH drug approval nearing? Intercept stages comeback as FDA sets decision date

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss

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

AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use

Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro

Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

FDA clears Braeburn's long-acting Braxadi to treat opioid use disorder

Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion

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

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

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

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