Bio Pharma Dive

AUGUST 25, 2023

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

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FDA Approval Regulation Drugs Medicine 246

Bio Pharma Dive

OCTOBER 13, 2023

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

FDA Approval 298

FDA Approval Drugs Marketing 298

Bio Pharma Dive

AUGUST 29, 2023

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

FDA Approval 298

FDA Approval Medicine Drugs Marketing 298

Pharmaceutical Technology

OCTOBER 18, 2024

The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s path to market.

FDA Approval 130

FDA Approval Drugs Marketing 130

Bio Pharma Dive

SEPTEMBER 21, 2021

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

FDA Approval 297

FDA Approval Drugs Antibody Medicine 297

Bio Pharma Dive

FEBRUARY 17, 2023

Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.

FDA Approval 345

FDA Approval Drugs Marketing 345

Bio Pharma Dive

SEPTEMBER 16, 2021

Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.

FDA Approval 290

FDA Approval Drugs Gene Marketing 290

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. We expect this important innovation to be commercially available in the US market by the end of June 2023.”

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FDA Approval Trials Medicine Drugs 246

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

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FDA Approval Drugs Gene Trials 52

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

Fierce Pharma

NOVEMBER 16, 2023

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

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FDA Approval Marketing Drugs 115

Bio Pharma Dive

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

FDA Approval 189

FDA Approval Drugs Protein Antibody 189

XTalks

OCTOBER 22, 2024

Astellas Pharma has won approval from the US Food and Drug Administration (FDA) for Vyloy (zolbetuximab) as a first-line treatment for adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The drug is specifically indicated for patients whose tumors are HER2-negative and express claudin 18.2

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FDA Approval Drugs Licensing Licensing 99

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

FDA Approval 264

FDA Approval Life Science Genetics Trials 264

Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Luye Pharma Group’s Rykindo (risperidone) as an extended-release injectable suspension to treat schizophrenia in adult patients. Rykindo has also been approved as a single agent or as adjunctive therapy to lithium or valproate to treat bipolar I disorder in these patients.

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FDA Approval Production Development Marketing 162

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

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FDA Approval Drugs Immune Response Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 30, 2022

Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market. Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye.

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Gene Therapy FDA Approval Gene Genetic Disease 289

Bio Pharma Dive

AUGUST 5, 2023

The agency turned back the companies' attempt to also win clearance for major depressive disorder, limiting its market potential.

FDA Approval 246

FDA Approval Drugs Marketing 246

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. Rizafilm, the US market name for Rizaport outside of the US, is administered via an oral soluble film.

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FDA Approval Bioequivalency Manufacturing Marketing 246

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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Gene Therapy FDA Approval Gene Clinical Trials 101

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

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FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JUNE 14, 2023

All six treatments are US Food and Drug Administration (FDA) approved. At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close. The company has a market cap of $20m.

FDA Approval 130

FDA Approval Cardiology Marketing Vaccine 130

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

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FDA Approval In-Vivo In-Vitro Trials 130

Bio Pharma Dive

JANUARY 13, 2023

The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others.

FDA Approval 290

FDA Approval Marketing Drugs 290

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

FDA Approval 130

FDA Approval Genetics Trials Medicine 130

Bio Pharma Dive

JULY 29, 2021

An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs.

FDA Approval 328

FDA Approval Insulin Production Marketing 328

XTalks

NOVEMBER 28, 2023

Kesin Pharma has obtained approval from the US Food and Drug Administration (FDA) for its oral suspension antibiotic drug Likmez (metronidazole), designed for patients with dysphagia and difficulty swallowing. Likmez offers a safer alternative by mitigating the associated risks linked to off-label drug compounding.

FDA Approval 92

FDA Approval Bacteria DNA Drugs 92

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Indivior’s Opvee (nalmefene) nasal spray to reverse opioid overdose. Indivior will begin offering Opvee in the market in the fourth quarter of 2023. Opvee was added to Indivior’s portfolio through the purchase of Opiant Pharmaceuticals in March 2023.

FDA Approval 130

FDA Approval Trials Marketing Development 130

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women.

FDA Approval 189

FDA Approval Drugs Trials Marketing 189

XTalks

JUNE 26, 2023

has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021.

FDA Approval 83

FDA Approval Drugs Sales In-Vitro 83

Pharmaceutical Technology

NOVEMBER 16, 2023

Augtyro (repotrectinib) is the only FDA-approved tumour kinase inhibitor (TKI) for ROS1-positive non-small cell lung cancer (NSCLC).

FDA Approval 130

FDA Approval Marketing Drugs 130

Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130

pharmaphorum

JUNE 27, 2024

Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available (..)

FDA Approval 114

FDA Approval Drugs Marketing Branding 114

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

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Drugs FDA Approval Development Production 246

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

XTalks

JUNE 17, 2024

Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines. We are thrilled with the FDA’s approval of Letybo.

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52