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 326

FDA Approval Insulin Production Marketing 326

Pharmaceutical Technology

MARCH 8, 2023

The regulatory approval marks the company’s first product to receive approval in the US market. 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.

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Bio Pharma Dive

APRIL 4, 2023

The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.

FDA Approval 322

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Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

FDA Approval 284

FDA Approval Drugs Protein Marketing 284

Pharmaceutical Technology

FEBRUARY 2, 2023

The European Medicines Agency is currently reviewing a marketing authorisation application for daprodustat and a regulatory decision is expected in the first half of this year. The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology.

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FDA Approval Life Science Genetics Trials 264

Bio Pharma Dive

OCTOBER 13, 2023

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

FDA Approval 293

FDA Approval Drugs Marketing 293

Pharmaceutical Technology

FEBRUARY 12, 2025

Merck acquisition target SpringWorks will go toe-to-toe with AstraZeneca in the US neurofibromatosis market.

FDA Approval 264

FDA Approval Drugs Marketing 264

Pharmaceutical Technology

JULY 2, 2024

Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.

FDA Approval 264

FDA Approval Branding Marketing 264

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.

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FDA Approval Drugs Antibody Medicine 291

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 284

FDA Approval Drugs Gene Marketing 284

Pharmaceutical Technology

SEPTEMBER 19, 2022

“For the ALD community, this long-awaited approval represents significant hope and offers families a new option where, for many, there had been none.”. In June 2019, the European Commission granted conditional marketing authorisation for bluebird bio’s Zynteglo to treat transfusion-dependent ?-thalassemia. thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

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 293

FDA Approval Medicine Drugs Marketing 293

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 284

FDA Approval Marketing Drugs 284

XTalks

NOVEMBER 7, 2024

Emrosi consists of minocycline, a tetracycline antibiotic, to target bacterial infection that can underlie rosacea. Research suggests that certain bacteria, particularly those associated with Demodex mites (tiny mites that naturally live on human skin) like Bacillus oleronius , could contribute to rosacea in some individuals.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

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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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.

FDA Approval 147

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Bio Pharma Dive

MARCH 31, 2022

While a market downturn has weighed on the biotech industry, FDA approvals for drugs from Bristol Myers Squibb, Bluebird bio and Amylyx Pharmaceuticals could help the sector regain its footing.

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Pharmaceutical Technology

APRIL 18, 2023

The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. Rizafilm, the US market name for Rizaport outside of the US, is administered via an oral soluble film. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.

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FDA Approval Bioequivalency Marketing Manufacturing 246

Bio Pharma Dive

JANUARY 20, 2021

The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study.

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FDA Approval Medicine Drugs Marketing 235

Pharmaceutical Technology

SEPTEMBER 27, 2024

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market.

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FDA Approval Marketing Antibody Drugs 162

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

AUGUST 8, 2022

The companies will co-market the therapy in the region and will be made available soon. The latest approval is based on one-year efficacy and safety findings, including 24-week data from the Phase III SPIRIT 1 and SPIRIT 2 clinical, as well as the first 28 weeks of an open-label extension study in those who completed either SPIRIT 1 or 2. .

FDA Approval 189

FDA Approval Drugs Trials Marketing 189

Pharmaceutical Technology

NOVEMBER 30, 2022

Gilead Sciences has received the European Commission’s (EC) expanded marketing authorisation for Biktarvy (bictegravir 30mg / emtricitabine 120mg / tenofovir alafenamide 15mg tablets) for treating human immunodeficiency virus (HIV) infection in virologically suppressed children.

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XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

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FDA Approval Gene Therapy Gene Genetics 59

Pharmaceutical Technology

JANUARY 16, 2023

It is claimed to be the first advanced therapy from the company’s central nervous system (CNS) product portfolio for marketing in the US. Rykindo is our first new drug developed in-house and approved for marketing in the US, demonstrating our long-standing commitment to serving patients around the world with innovative therapies.

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FDA Approval Production Development Marketing 162

Fierce Pharma

JULY 11, 2024

Alzheimer’s disease marketing at Eli Lilly, said during a recent interview.

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FDA Approval Marketing Antibody 111

Bio Pharma Dive

OCTOBER 21, 2022

The FDA will soon decide whether to pull Covis’ Makena from the market, more than three years after its confirmatory study failed. The delay highlights the need for reforms to the accelerated approval program, critics say.

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FDA Approval Drugs Marketing 218

XTalks

JANUARY 2, 2025

(ATGC) has gone public with its initial public offering (IPO), marking a significant milestone in its journey to transform the heart valve market. Trading began on the Nasdaq Global Market on December 13, 2024, under the ticker symbol “AVR,” with the offering closed on December 16, 2024. The company offered 14.8

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FDA Approval Marketing Clinical Trials Clinical Trials 110

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.

FDA Approval 246

FDA Approval Pharmacy Marketing Drugs 246

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.

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FDA Approval Drugs Protein Antibody 184

Pharmaceutical Technology

MARCH 4, 2025

Genentechs label expansion for TNKase consolidates its market position for pharmacological stroke treatments.

FDA Approval 147

FDA Approval Marketing 147

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 108

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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FDA Approval Marketing 99

Pharmaceutical Technology

FEBRUARY 1, 2023

Ellipses Pharma CEO and founder Dr Rajan Jethwa said: “This FDA approval of EP0042’s Investigational New Drug application allows us to open additional trial sites in the world’s foremost pharmaceutical market. The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

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). Ipsen is also seeking marketing approval from the European Medicines Agency, with a final decision expected in the second half of 2023.

FDA Approval 130

FDA Approval Genetics Trials Medicine 130

Pharmaceutical Technology

MAY 1, 2023

The approval of Uzedy is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

Pharmaceutical Technology

JULY 30, 2024

Collegium will pay $525m upfront to add Ironshore’s FDA-approved ADHD medication Jornay PM to its portfolio.

FDA Approval 147

FDA Approval Marketing 147