2023 and FDA - Pharma Rep Focus

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

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

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

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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

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

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

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

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

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

After rejection, FDA re-accepts Xspray's application for would-be rival to BMS' Sprycel

Fierce Pharma

FEBRUARY 12, 2024

With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer. The FDA is now expected to decide on Dasynoc by July 31.

FDA

FDA Pharma

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

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

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

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

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

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

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

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

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

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

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

With FDA nod for rare disease drug Rivfloza, Novo Nordisk eyes showdown with Alnylam

Fierce Pharma

OCTOBER 2, 2023

With FDA nod for rare disease drug Rivfloza, Novo Nordisk eyes showdown with Alnylam esagonowsky Mon, 10/02/2023 - 13:15

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

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

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

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

Roche's star eye drug Vabysmo crosses blockbuster threshold as rival stalls at FDA

Fierce Pharma

JULY 27, 2023

Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark in the first half of 2023. .” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.”

FDA

FDA Pharma Sales

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

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

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

Bristol Myers slashes Revlimid sales projection by $1B, now sees overall revenue decline in 2023

Fierce Pharma

JULY 27, 2023

Securing FDA approvals last year for three drugs that each have peak sales potential of $4 billion bodes well for the long-term future of Bristol Myers Squibb. And it's projecting overall sales decline for 2023. Bristol Myers Squibb is entering a dark stage.

Sales

Sales FDA

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

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

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

Fierce Pharma Asia—Carvykti faces FDA adcomm; AZ drug picks up world-first approval; Samsung Bio's year of growth

Fierce Pharma

JANUARY 25, 2024

The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. | The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. Samsung Biologics tallied an “exceptional” year in 2023.

FDA

FDA Pharma

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

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

AbbVie's Qulipta gains edge on Pfizer's Nurtec with FDA approval to prevent chronic migraines

Fierce Pharma

APRIL 18, 2023

AbbVie's Qulipta gains edge on Pfizer's Nurtec with FDA approval to prevent chronic migraines zbecker Tue, 04/18/2023 - 11:09

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

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

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

Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed

Fierce Pharma

NOVEMBER 9, 2023

Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed kdunleavy Thu, 11/09/2023 - 10:56

FDA

After delays, bluebird's sickle cell gene therapy finally lands at the FDA's desk

Fierce Pharma

APRIL 24, 2023

After delays, bluebird's sickle cell gene therapy finally lands at the FDA's desk zbecker Mon, 04/24/2023 - 11:15

FDA

Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

JANUARY 29, 2024

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance.

Pharmaceutical

Pharmaceutical Food and Drug Administration Medicine FDA

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

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

Webinars

Trending Sources

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

Webinars

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

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

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

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

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

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

After rejection, FDA re-accepts Xspray's application for would-be rival to BMS' Sprycel

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

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

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

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

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

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

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

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

Apellis wins FDA approval for first geographic atrophy drug

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

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

With FDA nod for rare disease drug Rivfloza, Novo Nordisk eyes showdown with Alnylam

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

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

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

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

Roche's star eye drug Vabysmo crosses blockbuster threshold as rival stalls at FDA

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

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

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

Bristol Myers slashes Revlimid sales projection by $1B, now sees overall revenue decline in 2023

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

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

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

Fierce Pharma Asia—Carvykti faces FDA adcomm; AZ drug picks up world-first approval; Samsung Bio's year of growth

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

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

AbbVie's Qulipta gains edge on Pfizer's Nurtec with FDA approval to prevent chronic migraines

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

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

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

Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed

After delays, bluebird's sickle cell gene therapy finally lands at the FDA's desk

Pharmaceutical industry: 2023 in retrospect

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