Fierce Pharma

AUGUST 7, 2024

The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line. | The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line.

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Fierce Pharma

AUGUST 14, 2024

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

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Fierce Pharma

SEPTEMBER 17, 2024

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

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Fierce Pharma

OCTOBER 17, 2024

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in (..)

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Fierce Pharma

SEPTEMBER 20, 2024

Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday. That changed Friday.

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Fierce Pharma

SEPTEMBER 16, 2024

Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S.

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Fierce Pharma

OCTOBER 23, 2024

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and (..)

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Fierce Pharma

SEPTEMBER 20, 2024

The FDA approved Zevra’s arimoclomol capsules to treat the rare lysosomal storage disorder Niemann-Pick disease type C in conjunction with Johnson & Johnson’s enzyme inhibitor miglustat. Arimoclomol, which will fly under the brand name Miplyffa, is now the first FDA-approved therapy for NPC.

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Fierce Pharma

AUGUST 23, 2024

The FDA has authorized the use of | The FDA has authorized the use of new vaccines from Pfizer/BioNTech and Moderna which have been designed to defend against the Omicron KP.2 2 variant of SARS-CoV-2. The nod comes as word of a new omicron variant, KP.3.1.1, is beginning to eclipse KP.2

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Fierce Pharma

OCTOBER 29, 2024

The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained. . | Novartis didn't use a priority review voucher for Pluvicto's key application in an earlier treatment setting of prostate cancer.

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Fierce Pharma

OCTOBER 18, 2024

After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel hemophilia treatment concizumab.

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Fierce Pharma

AUGUST 2, 2024

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

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Fierce Pharma

JUNE 26, 2024

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered partnered antibody drug conjugate (ADC) patritumab deruxtecan. |

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Fierce Pharma

AUGUST 16, 2024

AstraZeneca has scored an FDA approval in the advancement of its hi | AstraZeneca has scored an FDA approval in the advancement of its high-flying cancer therapy Imfinzi that comes with some controversy. The nod is for Imfinzi to treat patients with resectable non-small cell lung cancer perioperatively.

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Fierce Pharma

AUGUST 13, 2024

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing (..)

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Fierce Pharma

AUGUST 20, 2024

A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso. | A new FDA approval has vaulted a Johnson & Johnson lung cancer drug combination into a key territory already dominated by AstraZeneca’s Tagrisso.

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Fierce Pharma

AUGUST 12, 2024

After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S. Ascendis Pharma should be well prepared for the U.S.

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Fierce Pharma

OCTOBER 29, 2024

The FDA has approved the first abuse-deterrent, immediate-release, 10 mg opioid tablet for pain management. The drug, Roxybond, has been approved in other dosages.

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Fierce Pharma

SEPTEMBER 19, 2024

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more. 26 to Sept.

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Fierce Pharma

JUNE 17, 2024

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning (..)

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Fierce Pharma

SEPTEMBER 20, 2024

The FDA signed off on AstraZeneca's influenza vaccine FluMist for self-administration by adults up to 49 years old and for administration by a parent or caregiver in kids between the ages of 2 and 17. AstraZeneca has just scored big on the quest to make routine vaccinations less of a hassle. | patients can give to themselves.

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Fierce Pharma

AUGUST 26, 2024

Five months after the FDA rejected Regeneron’s bid for acc | Five months after the FDA rejected Regeneron’s bid for accelerated approval of its T-cell engager odronextamab because of the immaturity of its confirmatory trial, the European Union has signed off on the treatment for two types of blood cancers.

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Fierce Pharma

MAY 30, 2024

In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. | In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy.

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Fierce Pharma

MAY 8, 2024

In a letter to FDA Commissioner Robert Califf, M.D., Amid a U.S. | the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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Fierce Pharma

NOVEMBER 28, 2023

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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Fierce Pharma

MAY 31, 2024

With the FDA nod, Moderna's RSV vaccine becomes the company's second product to secure the FDA's backing.

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Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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Fierce Pharma

SEPTEMBER 26, 2024

A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

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Fierce Pharma

SEPTEMBER 13, 2024

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq. (..)

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Fierce Pharma

SEPTEMBER 5, 2024

With dwindling funds after a prior snub from the FDA, ImmunityBio’s journey to bag approval for its Merck-rivaling bladder cancer drug Anktiva wasn’t easy. | The drugmaker laid off 20 employees as it attempts to recoup from dwindling funds during its Anktiva launch in bladder cancer.

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Fierce Pharma

JULY 24, 2024

From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.

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Fierce Pharma

AUGUST 22, 2024

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept.

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MedCity News

OCTOBER 24, 2024

This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. The post 4 Things That Worry FDA Commissioner Robert Califf appeared first on MedCity News.

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Fierce Pharma

AUGUST 1, 2024

Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.” | Novartis has filed a lawsuit against the FDA, claiming that the U.S. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories.

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Fierce Pharma

AUGUST 30, 2024

As a new deadly strain of mpox continues its global spread, Emergent BioSoultion's smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus.

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Fierce Pharma

SEPTEMBER 18, 2024

Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off (..)

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Fierce Pharma

APRIL 1, 2024

What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA. What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA.

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