New Drug Approvals

APRIL 2, 2025

The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. 11] The FDA granted the application for suzetrigine priority review , fast track , and breakthrough therapy designations. [2] Pain Signal Inhibitor for the Treatment of Moderate to Severe Pain” Pain and Therapy.

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New Drug Approvals

JULY 25, 2025

Corticosteroid therapy is the current standard of care for DMD despite relatively high rates of adverse effects. 75,76 This also results in decreased glucocorticoid receptor-drive transactivation, ultimately improving the safety profile of vamorolone as compared to other corticosteroid therapies. 77 Readily available steroid 9.1

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New Drug Approvals

JUNE 29, 2025

1] [2] Adverse effects The FDA prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. [1] Food and Drug Administration.

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International FDA Clinical Trials Treatment 62

New Drug Approvals

MAY 8, 2025

MORE US10918622 US10695323 US10464905 US10342780 US12109193 Medical uses In the United States, pirtobrutinib is indicated to treat relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. [1] 5] It is taken by mouth. [1] 2] PATENTS Guisot, N.

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New Drug Approvals

APRIL 11, 2025

. ^ “Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors” Sanofi (Press release). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75” WHO Drug Information. 28 March 2025. Retrieved 29 March 2025. hdl : 10665/331046.

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BioPharma Drive: Drug Pricing

JUNE 11, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. You can unsubscribe at anytime.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease.

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Disease Licensing Licensing Therapies 109

New Drug Approvals

MAY 15, 2025

. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77” WHO Drug Information. New Drug Therapy Approvals 2023 (PDF). hdl : 10665/331020.

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FDA Approval FDA Treatment International 62

BioPharma Drive: Drug Pricing

JULY 16, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025.

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Therapies FDA Clinical Trials Licensing 304

BioPharma Drive: Drug Pricing

JULY 10, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Kennedy Jr., who has pushed for policy changes around mRNA vaccines in particular. Recommended Reading Medical groups, pregnant doctor sue RFK Jr.

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Vaccine FDA Therapies Licensing 231

BioPharma Drive: Drug Pricing

JULY 18, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Study researchers concluded hormonal therapy should not be used for chronic disease prevention, but is “appropriate for symptom management in some women.”

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Therapies FDA Clinical Trials Licensing 220

BioPharma Drive: Drug Pricing

JULY 18, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S.

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Therapies FDA Clinical Trials Licensing 159

BioPharma Drive: Drug Pricing

JULY 10, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Until Vykat came along, though, no drug therapies were specifically approved to curb the all-consuming hunger that hallmarks the condition. Since the drug’s U.S.

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Drugs Licensing Licensing Therapies 243

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] New Drug Therapy Approvals 2024 (PDF). 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2]

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FDA FDA Approval Drugs Trials 62

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. You can unsubscribe at anytime.

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RNA Drugs Therapies Licensing 219

New Drug Approvals

APRIL 19, 2025

New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. National Center for Biotechnology Information (NCBI). Retrieved 28 November 2024 via Business Wire. Jump up to: a b “Novel Drug Approvals for 2024” U.S. 1 October 2024.

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FDA Clinical Trials Treatment Trials 62

BioPharma Drive: Drug Pricing

JULY 14, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. With the new funds, PCI intends to expand its geographic reach as well as its capacity to manufacture specialized medicines and “fill-finish” facilities for injectable therapies.

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Production Drugs Therapies Clinical Trials 152

BioPharma Drive: Drug Pricing

JULY 2, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published July 2, 2025 By Kristin Jensen post share post print email license Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen.

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Clinical Trials Drugs Licensing Therapies 240

BioPharma Drive: Drug Pricing

JULY 9, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. 21, 2020.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory.

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Licensing Licensing Therapies Vaccine 117

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer.

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Therapies FDA Treatment Licensing 178

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. You can unsubscribe at anytime. Meanwhile, the former FDA leader authored an editorial critical of a new policy for COVID-19 shots.

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Vaccine FDA Therapies Licensing 130

BioPharma Drive: Drug Pricing

JULY 22, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. The drug blocks a protein called IL-23 that’s targeted by other available medicines, but, unlike those therapies, is delivered as a pill instead of an injection.

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FDA Specialty Pharmacies Drugs Therapies 152

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Therapies FDA FDA Approval Treatment 119

BioPharma Drive: Drug Pricing

JULY 22, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. You can unsubscribe at anytime. billion upfront to buy Vicebio and gain access to non-mRNA vaccine candidates against RSV, metapneumovirus and parainfluenza.

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Vaccine Clinical Trials FDA Therapies 144

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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Therapies Engineering Molecular Biology Science 105

The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc. Source link.

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The Pharma Data

MARCH 30, 2021

Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.

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Therapies Licensing Licensing Protein Expression 52

Drug Hunter

JUNE 25, 2023

This edition includes Maze’s glycogen synthase 1 (GYS1) inhibitors that were recently licensed to Sanofi, allosteric androgen receptor (AR) modulators that may be of interest to targeted protein degradation researchers, and brain-penetrant HER2 and ROCK2 inhibitors. Get ahead now by requesting a trial. already a member?

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Targeted Protein Degradation Computational Chemistry Trials Licensing 130

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Skip to main content Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Side effects and patient considerations Common side effects such as nausea and diarrhea affect some patients and can lead to discontinuation of therapy. You can unsubscribe at anytime.

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Treatment Drugs Therapies FDA 130

The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. is biotechnology company focused on developing radiopharmaceutical imaging and therapy agents.

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Licensing Licensing Clinical Trials Pharmaceutical Companies 52

The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. About Omidubicel.

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Licensing Licensing Clinical Trials FDA 52

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Licensing Licensing Vaccine FDA 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. IMPORTANT SAFETY INFORMATION FROM U.S.

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Licensing Licensing Vaccine FDA Approval 52

Conversations in Drug Development Trends

OCTOBER 26, 2022

That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities. All parties need to be thoroughly informed about what to expect and agreed-upon boundaries should be set in case the session becomes challenging.

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The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. .

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Therapies Virus Disease Licensing 52

The Pharma Data

JANUARY 3, 2021

(Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that U.S. GM1 is a rare and often life-threatening CNS disorder with no approved disease-modifying therapies available. About PBGM01.

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Therapies FDA Treatment Clinical Trials 52