Fierce Pharma

NOVEMBER 7, 2024

An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) Elevidys has sparked a new surge in sales for the gene therapy. | An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy Elevidys has sparked a new surge in sales.

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Fierce Pharma

NOVEMBER 1, 2024

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | said in an interview with Fierce Pharma.

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Fierce Pharma

NOVEMBER 8, 2024

Common oral medicines that have been used for decades as decongestants such as Sudafed, NyQuil and Benadryl may soon be cleared from shelves as the FDA has

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Fierce Pharma

OCTOBER 11, 2024

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

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Fierce Pharma

OCTOBER 25, 2024

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. The FDA nod marks the second approval this year for a uUTI medicine after two decades of stagnation in the field.

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Fierce Pharma

OCTOBER 14, 2024

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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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

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

SEPTEMBER 23, 2024

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis. (..)

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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

NOVEMBER 11, 2024

Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. Watch out, Gilead and Novartis: there's a new CAR-T in town. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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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

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

NOVEMBER 15, 2024

Azurity Pharmaceuticals has earned an FDA approval for Danziten, a new formulation of Novartis’ chronic myeloid leukemia (CML) blockbuster Tasigna.

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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

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

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

NOVEMBER 1, 2024

On Halloween, Lexicon was haunted again as an FDA advisory committee voted 11-3 to reject Zynquista as an accompanying medication to insulin for those with type 1 diabetes (T1D).

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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

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 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

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

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

NOVEMBER 12, 2024

Intercept received a complete response letter from the FDA, dashing the company’s hopes of turning Ocaliva’s accelerated green light into a traditional approval for the rare autoimmune disease primary biliary cholangitis.

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Fierce Pharma

APRIL 26, 2024

Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. | Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an FDA approval for the acquired treatment.

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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

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

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 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

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

FEBRUARY 16, 2024

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA (..)

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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

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

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

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

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

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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