Novavax seeks FDA approval for updated Covid-19 vaccine
Pharmaceutical Technology
JUNE 17, 2024
Novavax has sought US FDA approval for an updated JN.1 1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.
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FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
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MAY 30, 2024
The US FDA approved Teva Pharmaceuticals’ AUSTEDO XR as a once-daily treatment option for tardive dyskinesia and Huntington’s disease chorea.
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WestGene wins FDA approval for mRNA vaccine to treat certain cancers
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
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Botanix’s hyperhidrosis treatment Sofdra gains FDA approval
Pharmaceutical Technology
JUNE 20, 2024
Botanix Pharmaceuticals announced the receipt of FDA approval for Sofdra for excessive underarm sweating or primary axillary hyperhidrosis.
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FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension
Pharmaceutical Technology
MARCH 25, 2024
The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.
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Samsung Bioepis’ PYZCHIVA gains FDA approval as Stelara biosimilar
Pharmaceutical Technology
JULY 2, 2024
Samsung Bioepis has received US FDA approval for PYZCHIVA (ustekinumab-ttwe / SB17) as a biosimilar to Stelara for various indications.
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FDA approves Amgen’s BLINCYTO for acute lymphoblastic leukaemia
Pharmaceutical Technology
JUNE 17, 2024
The FDA approved Amgen’s BLINCYTO for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL).
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AbbVie’s SKYRIZI gains US FDA approval for ulcerative colitis
Pharmaceutical Technology
JUNE 19, 2024
AbbVie has received FDA approval for SKYRIZI to treat adult patients with moderately to severely active ulcerative colitis.
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AstraZeneca Imfinzi regimen for endometrial cancer gains FDA approval
Pharmaceutical Technology
JUNE 17, 2024
AstraZeneca's Imfinzi has received US FDA approval for treating adults with primary advanced or recurrent endometrial cancer.
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Xolair amplifies reach after FDA approval for treating food allergies
Pharmaceutical Technology
FEBRUARY 20, 2024
Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.
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Bristol Myers Squibb’s Breyanzi gains FDA approval for lymphoma
Pharmaceutical Technology
MAY 31, 2024
Bristol Myers Squibb (BMS) has received FDA approval for Breyanzi to treat adults with relapsed or refractory mantle cell lymphoma.
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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo
Pharmaceutical Technology
MAY 19, 2023
It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly. Bausch + Lomb chairman and CEO Brent Saunders stated: “Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease.
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GSK’s RSV vaccine receives FDA approval for adults aged 50 to 59
Pharmaceutical Technology
JUNE 10, 2024
The US FDA approved GSK's Arexvy, an RSV vaccine for adults aged 50 to 59 years at higher lower respiratory tract disease (LRTD) risk.
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AstraZeneca’s Imfinzi Gets FDA Approval for Treating Endometrial Cancer
BioSpace
JUNE 16, 2024
AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
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Rystiggo receives FDA approval, strengthening UCB’s myasthenia gravis portfolio
Pharmaceutical Technology
JUNE 27, 2023
UCB's Rystiggo has been granted FDA approval to treat myasthenia gravis in anti-AchR or anti-MuSK antibody-positive adults.
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Roctavian and BioMarin’s $2.9m haemophilia gene therapy secures FDA approval
Pharmaceutical Technology
JUNE 30, 2023
BioMarin’s Roctavian, a one-time therapy for severe haemophilia A, has secured FDA approval following previous rejections and delays.
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FDA approves Ipsen’s Onivyde for pancreatic adenocarcinoma
Pharmaceutical Technology
FEBRUARY 14, 2024
Ipsen reported that the US FDA approved the Onivyde regimen (NALIRIFOX) as a first-line treatment for metastatic pancreatic cancer.
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Iovance’s Amtagvi for melanoma treatment gains FDA approval
Pharmaceutical Technology
FEBRUARY 19, 2024
Iovance Biotherapeutics' Amtagvi has received accelerated US FDA approval for treating adults with metastatic or unresectable melanoma.
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Takeda’s EOHILIA receives FDA approval for EoE treatment
Pharmaceutical Technology
FEBRUARY 13, 2024
Takeda has received the US FDA approval for EOHILIA (budesonide oral suspension), an oral treatment for eosinophilic esophagitis (EoE).
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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia
Pharmaceutical Technology
MARCH 2, 2023
“As a company, this is a transformative milestone highlighting our commitment to developing and commercialising novel therapies for patients with severe diseases with few or no approved therapies.” The post US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia appeared first on Pharmaceutical Technology.
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Calliditas receives FDA approval for Tarpeyo to treat IgAN
Pharmaceutical Technology
DECEMBER 21, 2023
Calliditas Therapeutics has received the US FDA approval for Tarpeyo to treat adult primary immunoglobulin A nephropathy (IgAN) patients.
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FDA approves Takeda’s targeted therapy for advanced colon cancer
Pharmaceutical Technology
NOVEMBER 13, 2023
On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).
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FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology
JUNE 3, 2024
Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).
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US FDA approves Shorla’s oncology drug for T-cell leukaemia
Pharmaceutical Technology
MARCH 8, 2023
Shorla Oncology CEO and co-founder Sharon Cunningham said: “We are very proud to see our research in oncology innovation and dedication to patient care culminate in this US FDA approval. The post US FDA approves Shorla’s oncology drug for T-cell leukaemia appeared first on Pharmaceutical Technology.
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MSD’s Welireg secures FDA approval for renal cell carcinoma
Pharmaceutical Technology
DECEMBER 15, 2023
This is the second FDA approval for MSD’s HIF-2α inhibitor following a 2021 approval to treat von Hippel-Lindau disease.
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Janssen seeks FDA approval for lung cancer combination therapy
Pharmaceutical Technology
NOVEMBER 21, 2023
Janssen has sought US FDA approval for the Rybrevant combination regimen for locally advanced or metastatic non-small cell lung cancer.
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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica
Pharmaceutical Technology
MARCH 1, 2023
With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”
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FDA approves AstraZeneca’s Farxiga for paediatric T2D patients
Pharmaceutical Technology
JUNE 13, 2024
The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.
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No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval
Fierce Pharma
JUNE 20, 2024
The med is the first new chemical entity to win FDA approval specifically to treat primary axillary hyperhidrosis, or excessive underarm sweating. It's also Botanix's first approved product. Everybody sweats, but for the 10 million people in the U.S.
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Novartis secures FDA approval for Pluvicto production at US plant
Pharmaceutical Technology
JANUARY 8, 2024
Novartis has received the US FDA approval to commercially manufacture Pluvicto at its new RLT manufacturing facility.
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FDA approves Amgen’s interchangeable biosimilar Bkemv
Pharmaceutical Technology
MAY 29, 2024
The US FDA has approved Amgen's Bkemv as an interchangeable biosimilar to Soliris for the treatment of specific rare diseases.
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FDA approves MSD’s KEYTRUDA for advanced endometrial cancer
Pharmaceutical Technology
JUNE 18, 2024
The US FDA has granted approval for MSD’s KEYTRUDA regimen to treat primary advanced or recurrent endometrial carcinoma in adults.
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Lilly challenges Wegovy dominance in weight loss market with FDA approval
Pharmaceutical Technology
NOVEMBER 9, 2023
Zepbound (tirzepatide) has been approved by the FDA approval and is expected to be launched in the US by the end of 2023.
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MSD leaps on FDA approval of PAH drug sotatercept
pharmaphorum
MARCH 26, 2024
MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms
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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor
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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FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 10, 2023
The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.
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US FDA approves Pfizer’s migraine nasal spray Zavzpret
Pharmaceutical Technology
MARCH 10, 2023
The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.
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Novaliq’s dry eye disease therapy receives US FDA approval
Pharmaceutical Technology
JUNE 9, 2023
Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE. Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks.
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US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy
Pharmaceutical Technology
MAY 23, 2023
The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients.
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GSK’s Ojjaara receives FDA approval for treating myelofibrosis patients with anaemia
Pharmaceutical Technology
SEPTEMBER 21, 2023
On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.
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Basilea Wins FDA Approval for Antibiotic Ending 15-Year Regulatory Quest
BioSpace
APRIL 3, 2024
Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.
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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer
Pharmaceutical Technology
AUGUST 12, 2022
The latest development comes after Enhertu received FDA approval for treating unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The post US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer appeared first on Pharmaceutical Technology.
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US FDA approves Apellis’ geographic atrophy therapy Syfovre
Pharmaceutical Technology
FEBRUARY 20, 2023
The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology. Vitreous floaters, ocular discomfort, conjunctival hemorrhage, and neovascular AMD were the most common adverse reactions observed in patients receiving Syfovre.
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AstraZeneca, Daiichi Sankyo Win First Tumor-Agnostic HER2 FDA Approval for Enhertu
BioSpace
APRIL 8, 2024
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu is the first FDA-approved tumor-agnostic HER2-targeted therapy authorized for the treatment of solid tumors in adults who have undergone prior systemic treatment.
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