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.
FDA Approval Related Topics 
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.
FDA Approval 
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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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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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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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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 Accord BioPharma’s HERCESSI for cancer treatment
Pharmaceutical Technology
SEPTEMBER 19, 2024
Accord BioPharma received FDA approval for 420mg HERCESSI, a biosimilar to Herceptin to treat various kinds of HER2-overexpressing cancers.
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FDA approves UCB’s BIMZELX for multiple inflammatory conditions
Pharmaceutical Technology
SEPTEMBER 24, 2024
UCB has received US FDA approval for BIMZELX (bimekizumab-bkzx) to treat adults with three inflammatory conditions.
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South Korean company Dong-A ST wins FDA approval for Stelara biosimilar
Pharmaceutical Technology
OCTOBER 11, 2024
Imuldosa is the latest FDA-approved biosimilar of J&J’s blockbuster therapy for the treatment of certain autoimmune diseases.
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Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
Fierce Pharma
OCTOBER 18, 2024
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2
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Xolair amplifies reach after FDA approval for treating food allergiesÂ
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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FDA approves Zevra Therapeutics’ Miplyffa for Niemann-Pick disease
Pharmaceutical Technology
SEPTEMBER 23, 2024
Zevra Therapeutics has gained FDA approval for Miplyffa (arimoclomol) to treat Niemann-Pick disease type C (NPC).
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FDA approves Azurity’s Nymalize oral solution in prefilled syringe
Pharmaceutical Technology
SEPTEMBER 4, 2024
Azurity Pharmaceuticals’ Nymalize oral solution in a 30mg/5ml prefilled ENFit syringe has received US FDA approval.
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FDA approves IASO Bio’s IND for equecabtagene autoleucel
Pharmaceutical Technology
AUGUST 12, 2024
IASO Biotherapeutics has secured the US Food and Drug Administration (FDA) approval equecabtagene autoleucel (Eque-cel).
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FDA approves IASO Bio’s IND for equecabtagene autoleucel
Pharmaceutical Technology
AUGUST 12, 2024
IASO Biotherapeutics has secured the US Food and Drug Administration (FDA) approval equecabtagene autoleucel (Eque-cel).
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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 Sun Pharma’s JAK inhibitor for alopecia
Pharmaceutical Technology
JULY 26, 2024
The FDA approval is based on data gathered from two Phase III studies where over 30% of the patients gained 80% or more coverage of scalp hair.
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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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Emergent gains FDA approval for ACAM2000 vaccine for Mpox
Pharmaceutical Technology
AUGUST 30, 2024
Emergent BioSolutions has received FDA approval for ACAM2000 to expand its use for the prevention of Mpox.
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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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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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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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UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals
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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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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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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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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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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Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer
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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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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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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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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After prior snub, Zevra clinches FDA approval for rare lysosomal storage disorder drug Miplyffa
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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Intercept’s liver disease drug Ocaliva faces FDA approval delay
Pharmaceutical Technology
OCTOBER 18, 2024
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary cholangitis.
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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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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 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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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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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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FDA approves Roche’s Tecentriq Hybreza for cancer
Pharmaceutical Technology
SEPTEMBER 13, 2024
The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.
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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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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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