FDA approves twice-yearly shot of Gilead drug for HIV prevention
Bio Pharma Dive
JUNE 18, 2025
The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.
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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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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 Johnson & Johnson’s Tremfya to treat Crohn’s disease
Pharmaceutical Technology
MARCH 21, 2025
J&J has received US FDA approval for Tremfya (guselkumab), to treat moderately to severely active Crohn's disease (CD) in adults.
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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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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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Celltrion’s Avtozma Receives FDA Approval, Making it the Third Actemra Biosimilar to Hit the Market
XTalks
FEBRUARY 5, 2025
Celltrions Actemra (tocilizumab) biosimilar Avtozma (tocilizumab-anoh) has received FDA approval for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) as well as COVID-19.
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Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma
XTalks
JANUARY 7, 2025
With FDA approval granted, Humacyte is working to make Symvess widely available in hospitals, trauma centers and military facilities, offering new treatment options for patients with vascular injuries. Symvess does carry risks, including thrombosis, graft rupture and infection.
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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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MSD receives FDA approval for Enflonsia to prevent RSV
Pharmaceutical Technology
JUNE 10, 2025
MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.
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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 Jylamvo for Pediatric Patients, Expanding Methotrexate Options
XTalks
OCTOBER 30, 2024
Shorla Oncology recently received US Food and Drug Administration (FDA) approval to expand Jylamvo ’s (methotrexate) use for children with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.
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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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FDA approves Selarsdi injection as interchangeable with Stelara
Pharmaceutical Technology
MAY 6, 2025
Teva and Alvotech have announced receipt of the US FDA approval to Selarsdi injection for use as an interchangeable with Stelara.
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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 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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Kebilidi FDA-Approved as First Brain-Delivered Gene Therapy for AADC Deficiency
XTalks
NOVEMBER 14, 2024
PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency.
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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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Novo says it’s submitted obesity pill for FDA approval
Bio Pharma Dive
APRIL 21, 2025
A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.
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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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Ryoncil Becomes First FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy
XTalks
JANUARY 6, 2025
The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for both conditions, with a Phase III confirmatory trial underway for CLBP.
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Journey slips on FDA approval of rosacea therapy
pharmaphorum
NOVEMBER 5, 2024
Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term (..)
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FDA approves J&J’s Imaavy for generalised myasthenia gravis
Pharmaceutical Technology
MAY 1, 2025
J&J's Imaavy (nipocalimab-aahu) has received US Food and Drug Administration (FDA) approval for treating generalised myasthenia gravis.
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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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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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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 Capsida’s CAP-003 gene therapy for Parkinson’s
Pharmaceutical Technology
JUNE 12, 2025
The FDA has approved Capsida Biotherapeutics' investigational new drug (IND) application for CAP-003 to treat Parkinson’s disease (PD).
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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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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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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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HIV prevention drug hailed as a 'breakthrough' gets FDA approval
NPR Health - Shots
JUNE 18, 2025
A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. One looming question: Will it be affordable for lower resource countries? Image credit: Nardus Engelbrecht)
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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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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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FDA approves Eton’s application for hydrocortisone oral solution
Pharmaceutical Technology
MAY 29, 2025
Eton Pharmaceuticals NDA for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval.
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FDA approves UroGen’s Zusduri to treat recurrent bladder cancer
Pharma Times
JUNE 17, 2025
UroGen’s president and chief executive officer, Liz Barrett, said the approval “represents a significant step forward for [the] company and for the treatment of recurrent LG-IR-NMIBC”. “For the first time,… US patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine,” Barrett said.
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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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Galderma wins FDA approval for skin condition treatment
Bio Pharma Dive
AUGUST 13, 2024
Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.
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FDA approves GSK’s Nucala to treat COPD
Pharmaceutical Technology
MAY 23, 2025
GSK has received approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab).
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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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Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research
Bio Pharma Dive
JANUARY 30, 2025
Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.
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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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Pfizer wins FDA approval of new meningococcal vaccine
Bio Pharma Dive
OCTOBER 23, 2023
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
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