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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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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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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FDA approves Ascendis Pharma’s YORVIPATH for hypoparathyroidism
Pharmaceutical Technology
AUGUST 13, 2024
Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.
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FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
Pharmaceutical Technology
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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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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Lilly’s EBGLYSS gains FDA approval for patients aged 12 and older
Pharmaceutical Technology
SEPTEMBER 16, 2024
Eli Lilly and Company has announced the FDA approval of EBGLYSS for treating atopic dermatitis in adults and children over 12.
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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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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 first microbiota-based treatment
Bio Pharma Dive
DECEMBER 1, 2022
The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.
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US FDA approves Ferring’s Rebyota for Clostridioides difficile infection
Pharmaceutical Technology
DECEMBER 1, 2022
Ferring Pharmaceuticals president Per Falk said: “This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development. The post US FDA approves Ferring’s Rebyota for Clostridioides difficile infection appeared first on Pharmaceutical Technology.
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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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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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FDA approves first gene therapy for hemophilia B
Bio Pharma Dive
NOVEMBER 22, 2022
The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5
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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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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 cancer drugs from Lilly, Menarini
Bio Pharma Dive
JANUARY 30, 2023
The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK.
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Madrigal wins FDA approval of first drug for MASH
Bio Pharma Dive
MARCH 14, 2024
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
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Ferring wins FDA approval for bladder cancer gene therapy
Bio Pharma Dive
DECEMBER 19, 2022
The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.
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FDA approves new ALS medicine in precedent-setting decision
Bio Pharma Dive
APRIL 25, 2023
Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.
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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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FDA approves new CAR-T competitor to Gilead’s Tecartus
Bio Pharma Dive
NOVEMBER 11, 2024
Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.
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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD
Pharmaceutical Technology
FEBRUARY 2, 2023
The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology. Last December, GSK and Wave Life Sciences entered a strategic partnership to drive the discovery and development of oligonucleotide therapies for new genetic targets.
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FDA approves first CAR-T cell therapy for multiple myeloma
Bio Pharma Dive
MARCH 27, 2021
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.
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5 FDA approval decisions to watch in the second quarter
Bio Pharma Dive
MARCH 29, 2021
A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.
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In first, FDA approves KRAS-blocking cancer drug from Amgen
Bio Pharma Dive
MAY 28, 2021
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.
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FDA approves first-of-its-kind lupus drug
Bio Pharma Dive
JANUARY 25, 2021
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.
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Bristol Myers finally wins FDA approval for cancer cell therapy
Bio Pharma Dive
FEBRUARY 5, 2021
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.
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5 FDA approval decisions to watch in the 1st quarter
Bio Pharma Dive
JANUARY 5, 2021
By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.
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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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Lilly wins FDA approval of new kind of diabetes drug
Bio Pharma Dive
MAY 13, 2022
Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.
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5 FDA approval decisions to watch in the 4th quarter
Bio Pharma Dive
SEPTEMBER 29, 2020
The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.
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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s
Pharmaceutical Technology
JANUARY 9, 2023
The post US FDA approves Eisai-Biogen’s antibody for Alzheimer’s appeared first on Pharmaceutical Technology. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial. The Amyloid-Related Imaging Abnormalities (ARIA) incidence profile of Leqembi was within expectations.
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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies
Pharmaceutical Technology
SEPTEMBER 30, 2022
These approvals represent crucial milestones for bluebird bio, the gene therapy field, and patients with rare genetic diseases. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.
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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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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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FDA approves new vitiligo treatment, bolstering Incyte's dermatology business
Bio Pharma Dive
JULY 19, 2022
The cream, known as Opzelura, is now the only treatment approved in the U.S. to repigment skin in patients with the most common form of vitiligo.
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BioMarin finally secures FDA approval of hemophilia gene therapy
Bio Pharma Dive
JUNE 29, 2023
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.
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US FDA approves Provention Bio’s Tzield to delay diabetes
Pharmaceutical Technology
NOVEMBER 18, 2022
The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology. They received a 14-day course of either teplizumab or a placebo. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.
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Bluebird wins FDA approval of gene therapy for rare brain disorder
Bio Pharma Dive
SEPTEMBER 17, 2022
The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million.
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FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults
Bio Pharma Dive
MAY 3, 2023
The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.
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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer
Pharmaceutical Technology
AUGUST 8, 2022
In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer. The post AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer appeared first on Pharmaceutical Technology.
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Lexicon gets FDA approval for Inpefa to treat heart failure
Pharmaceutical Technology
MAY 29, 2023
Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”
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