Drug Topics

MAY 13, 2024

Altuviiio was first granted approval by the FDA in February 2023.

Labelling 201

Labelling FDA 201

pharmaphorum

JANUARY 9, 2023

Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. The post JP Morgan 2023 – Day 1 appeared first on. Check below for updates throughout the day.

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FDA 119

Pharmacy Times

JULY 7, 2022

The FDA approved a licensure request for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent for use in the upcoming 2022-2023 flu season, providing influenza vaccination for adults 65 years of age and older.

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Vaccines FDA 123

Pharmacy Times

OCTOBER 3, 2023

NVX-CoV2601 vaccine adjuvanted 2023-2024 formula granted EUA for the prevention of COVID-19 in those 12 years of age and older.

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Vaccines FDA 145

pharmaphorum

AUGUST 17, 2022

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 The US regulator is due to make a decision on momelotinib by 16 June, 2023, on the basis of phase 3 results reported in January, said GSK.

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FDA 105

Pharmaceutical Commerce

AUGUST 30, 2023

Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.

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FDA 105

Drug Store News

AUGUST 23, 2023

FDA Commissioner Robert Califf will be the keynote FDA speaker during a “Fireside Chat” at GRx+Bosims 2023, which will be held Oct.

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FDA 52

Pharmaceutical Technology

DECEMBER 19, 2023

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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FDA 105

STAT

NOVEMBER 13, 2024

Meanwhile, the FDA conducted 621 foreign and 444 domestic inspections in fiscal year 2023, down 36% from fiscal year 2019. And as the FDA relies more on inspections of European facilities by European regulators, its own investigators are increasingly taking longer trips to India and China. government watchdog found.

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FDA 114

Pharmaceutical Technology

JANUARY 31, 2024

In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy.

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FDA 52

Pharmaceutical Technology

FEBRUARY 23, 2024

The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

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FDA 105

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.

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FDA 101

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.

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FDA 86

The Checkup by Singlecare

NOVEMBER 9, 2023

Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.

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FDA Labelling Insurance 120

Med Ed 101

OCTOBER 6, 2024

The medication was approved by the FDA in May of 2023 to improve […] The post Practice Update: Fezolinetant FDA Warning appeared first on Med Ed 101. This action inhibits neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron which alters activity in the thermoregulatory center of the brain.

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FDA 52

The FDA Law Blog

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. FDA Commissioner Robert M. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

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Insurance FDA Labelling 104

The FDA Law Blog

JANUARY 2, 2023

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. Recalls, product withdrawals, and FDA oversight authority.

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FDA Labelling 57

OctariusRx

JULY 31, 2023

Preview the new medications of 2023, as we reach the halfway point of the year. Food and Drug Administration (FDA) is constantly reviewing and approving new medications and the number of medications approved in recent years has drastically increased. The post Preview the New Medications of 2023 appeared first on OctariusRX.

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FDA 80

The Checkup by Singlecare

NOVEMBER 6, 2023

Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response.

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FDA Immunization 110

European Pharmaceutical Review

AUGUST 21, 2023

For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 trillion in the Q1 of 2023 to $3.56 trillion in Q2 2023. Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1

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Vaccines FDA 98

STAT

OCTOBER 17, 2024

In late 2023, after a rejection from the agency earlier in the year, Blue Note had made a last ditch attempt to convince the FDA that Attune, its mental health app for cancer patients, could fill an urgent unmet need. Eich was betting on the FDA clearance to propel Blue Note forward.

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FDA 116

Pharmacy Times

OCTOBER 19, 2023

The biosimilar landscape is growing, but the FDA should leverage analytical data to efficiently determine the quality of these products and propel them toward approval, according to a session at the Academy of Managed Care Pharmacy’s Nexus 2023 conference.

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FDA 139

The FDA Law Blog

MARCH 6, 2023

The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. In the proposed rule, FDA stated that any final rule would become effective one year after the date of publication of the final rule in the Federal Register.

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FDA 104

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023. Drug development in 2023 and beyond.

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FDA 98

The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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Documentation FDA Communication 57

Fierce Pharma

APRIL 19, 2023

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

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Vaccines FDA 145

STAT

JUNE 13, 2024

The day an FDA advisory committee met to weigh the merits of an experimental treatment for amyotrophic lateral sclerosis was one of the worst of Mitze Klingenberg’s life.    Her son Matt had benefited, she said, from an ALS treatment under review for approval by the Food and Drug Administration.

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FDA 128

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. stated, “ We appreciate the IOM’s report on the 510(k) program.

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Documentation FDA 62

Outsourcing Pharma

MARCH 29, 2022

The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.

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FDA 96

PharmaVoice

DECEMBER 6, 2023

This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

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FDA Vaccines 105

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 (..)

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FDA 117

Pharmaceutical Technology

MARCH 25, 2024

The FDA granted accelerated approval for the drug back in November 2022, and granted priority review in December 2023.

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FDA 98

Pharmaceutical Technology

SEPTEMBER 12, 2023

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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Vaccines FDA 111

pharmaphorum

DECEMBER 1, 2023

FDA starts review of Padcev/Keytruda for bladder cancer Phil.Taylor Fri, 01/12/2023 - 10:56 Bookmark this

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FDA 119

PharmaShots

MARCH 15, 2023

Shots: The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. vs 26.7%) during a median follow-up of 2.5yrs., patients with other AEs were similar in 2 groups, mean change in Hb level from baseline to 28-52wks. vs 26.7%) during a median follow-up of 2.5yrs.,

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FDA Insurance 40

STAT

JUNE 26, 2024

The FDA’s goal is to ensure that enrollment goals include clinically relevant study populations. The FDA is also required to publish guidance on diversity action plans. 29, 2023, deadline for the agency to circulate a draft, the biopharma industry is still waiting for it. But nearly half a year after a Dec.

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FDA 108

pharmaphorum

DECEMBER 15, 2023

MSD claims 2nd FDA approval for Welireg, in kidney cancer Phil.Taylor Fri, 15/12/2023 - 11:40 Bookmark this

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FDA 115