The Pharma Data

JUNE 9, 2025

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor).

FDA Approval 40

FDA Approval FDA Hospitals Clinical Trials 40

SugarCone Biotech

JUNE 19, 2025

Typical treatment has been chemotherapy and radiotherapy with an initially high overall response rate (ORR) but then rapid recurrence followed by poor prognosis. Toxicities were challenging enough to cause 13% of patients to reduce dose or skip doses and 3% to discontinue treatment. months (versus 20% ORR and 8.3

Therapies 78

Therapies Clinical Trials Treatment Clinical Development 78

New Drug Approvals

APRIL 11, 2025

2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] The label also has a warning about liver toxicity and the need to monitor liver blood tests at baseline and then monthly for at least six months after initiating treatment with fitusiran or after a dose increase of fitusiran. [2]

Clinical Trials 107

Clinical Trials FDA FDA Approval Trials 107

New Drug Approvals

MAY 17, 2025

Tofersen , sold under the brand name Qalsody , is a medication used for the treatment of amyotrophic lateral sclerosis (ALS). [3] 3] Tofersen was approved for medical use in the United States in April 2023, [3] [6] and in the European Union in May 2024. [4] Retrieved 17 April 2025. ^ “Qalsody- tofersen injection” DailyMed.

FDA Approval 62

FDA Approval FDA Treatment Clinical Trials 62

Drug Target Review

JUNE 5, 2025

Dr Aaron Haubner, Senior Manager of North America Medical Affairs and Market Access at Terumo Blood and Cell Technologies , reveals that while promising new treatments emerge, urgent partnerships are needed to ensure this essential blood therapy reaches the patients who need it most.

Disease 52

Disease Treatment Therapies Nurses 52

New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

FDA 62

FDA Therapies Trials Treatment 62

New Drug Approvals

APRIL 25, 2025

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 3] Inavolisib was approved for medical use in the United States in October 2024. [3] 8] Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy. Retrieved 17 April 2025.

FDA 57

FDA FDA Approval Therapies Trials 57

New Drug Approvals

JUNE 29, 2025

Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4 , Taletrectinib adipate FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer AB-106, DS-6051a 405.5 1] Taletrectinib was approved for medical use in the United States in June 2025. [3] April 2025. Hz, 3H) , 1.48-1.49

International 62

International FDA Clinical Trials Treatment 62

Broad Institute

MAY 21, 2025

All nominations for the 2025 Merkin Prize were evaluated by a selection committee composed of nine scientific leaders from academia and industry in the US and Europe. The work of June, Levine, Rivire, and Sadelain laid the foundation for a whole new class of treatments. The winners will be honored in a prize ceremony later this year.

Therapies 119

Therapies FDA Approval Engineering Immune Response 119

Broad Institute

JUNE 24, 2025

By Broad Communications June 24, 2025 Credit: Casey Atkins David Liu is a core member at the Broad Institute where he is the Richard Merkin Professor and director of the Merkin Institute for Transformative Technologies in Healthcare. Some of these treatments, like K.J.’s, The team that treated K.J. Today, K.J.

Treatment 133

Treatment Disease DNA Clinical Trials 133

New Drug Approvals

JULY 10, 2025

g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]

FDA 57

FDA Treatment Small Molecule International 57

The Pharma Data

JUNE 15, 2025

The new results were presented in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress. According to the data, the combination demonstrated a high ORR and a strong depth of response in a patient population with limited treatment options and poor outcomes under standard care.

Therapies 40

Therapies Treatment Disease FDA Approval 40

The Pharma Data

JULY 2, 2025

Food and Drug Administration’s (FDA) accelerated approval of Lynozyfic™ (linvoseltamab-gcpt), a first-in-class BCMAxCD3 bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) multiple myeloma (MM). Lynozyfic demonstrated early, deep, and durable responses in heavily pre-treated patients.

FDA 40

FDA FDA Approval Therapies Treatment 40

New Drug Approvals

MAY 15, 2025

5] Leniolisib was approved for medical use in the United States in March 2023. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 16 April 2025. 29 March 2023.

FDA Approval 62

FDA Approval FDA Treatment International 62

New Drug Approvals

APRIL 18, 2025

Formula C 27 H 29 Cl 2 FN 2 OS Crinecerfont , sold under the brand name Crenessity , is a medication used for the treatment of congenital adrenal hyperplasia. [1] 2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] Crinecerfont was approved for medical use in the United States in December 2024. [2]

FDA 62

FDA FDA Approval Drugs Trials 62

Codon

JUNE 5, 2025

.” Four years earlier, in 2019, Gray had become the first patient with sickle cell anemia — a genetic disorder that causes red blood cells to become sticky and rigid — to receive an experimental treatment using CRISPR genome editing. Therapeutics The first Cas13-based clinical trial was approved in 2024.

DNA 81

DNA RNA Clinical Trials Engineering 81

The Pharma Data

JULY 2, 2025

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.

Trials 52

Trials FDA Licensing Licensing 52

The Pharma Data

JUNE 13, 2025

FDA Approves KEYTRUDA® (Pembrolizumab) for Perioperative Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma Merck known as MSD outside the United States and Canada, recently announced that the U.S. Subsequently, KEYTRUDA is used as monotherapy following the completion of adjuvant therapy.

FDA Approval 40

FDA Approval Treatment FDA Therapies 40

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 9] It is used as landiolol hydrochloride.

FDA 62

FDA Clinical Trials Treatment Trials 62

Drugs.com

MAY 21, 2025

WEDNESDAY, May 21, 2025 -- The U.S. Food and Drug Administration has approved the humanized monoclonal antibody, Zynyz, (retifanlimab-dlwr) as the first first-line treatment for advanced anal cancer.Zynyz is a programmed death receptor-1 inhibitor.

FDA Approval 179

FDA Approval Treatment FDA Drugs 179

Drugs.com

JUNE 10, 2025

TUESDAY, June 10, 2025 -- The U.S. Food and Drug Administration has approved the Sonu Band, an artificial intelligence-enabled, wearable medical device for at-home treatment of moderate-to-severe nasal congestion in pediatric patients aged 12 and.

FDA Approval 179

FDA Approval Treatment FDA Drugs 179

FDA Law Blog: Drug Discovery

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L. Butler & Deborah L.

FDA 59

FDA Clinical Trials FDA Approval Trials 59

The Pharma Data

JUNE 24, 2025

Regeneron Unveils Groundbreaking $200 Million Donation Matching Program to Expand Patient Access to Vision-Saving Treatments Regeneron Pharmaceuticals , a leader in biotechnology and a longtime advocate for equitable healthcare access, has announced a bold new philanthropic initiative designed to support patients facing debilitating eye diseases.

Treatment 40

Treatment Disease Therapies FDA Approval 40

Drugs.com

FEBRUARY 5, 2025

5, 2025 -- The U.S. Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema.Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with diabetic. WEDNESDAY, Feb.

FDA Approval 288

FDA Approval FDA Treatment Drugs 288

Drugs.com

FEBRUARY 5, 2025

5, 2025 -- The U.S. Food and Drug Administration has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. The approval was based on the results of three phase 3 trials of. WEDNESDAY, Feb.

FDA Approval 261

FDA Approval Treatment FDA Trials 261

Drugs.com

JANUARY 22, 2025

22, 2025 -- The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants. WEDNESDAY, Jan.

FDA Approval 278

FDA Approval Treatment FDA Drugs 278

Drugs.com

FEBRUARY 6, 2025

6, 2025 -- The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with. THURSDAY, Feb.

FDA Approval 277

FDA Approval Disease FDA Treatment 277

Drugs.com

MARCH 6, 2025

THURSDAY, March 6, 2025 -- The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.TNKase is delivered as a single five-second.

FDA Approval 261

FDA Approval FDA Treatment Drugs 261

Drugs.com

MARCH 25, 2025

TUESDAY, March 25, 2025 -- The U.S. Food and Drug Administration has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women (weighing 40 kg or more) and children (12 years and older.

FDA Approval 266

FDA Approval FDA Treatment Drugs 266

Drugs.com

APRIL 23, 2025

WEDNESDAY, April 23, 2025 -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.The approval is for patients 12 years and older who remain.

FDA Approval 245

FDA Approval FDA Treatment Drugs 245

Drugs.com

APRIL 15, 2025

TUESDAY, April 15, 2025 -- The U.S. Food and Drug Administration has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC).The The CheckMate-9DW.

FDA Approval 200

FDA Approval FDA Treatment Drugs 200

Drugs.com

JANUARY 16, 2025

16, 2025 -- The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company.Omvoh targets. THURSDAY, Jan.

FDA Approval 162

FDA Approval Disease FDA Treatment 162

Drugs.com

APRIL 16, 2025

WEDNESDAY, April 16, 2025 -- The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who.

FDA Approval 147

FDA Approval FDA Treatment Drugs 147

Drug Target Review

JANUARY 8, 2024

Our lead program utilises OSK for the treatment of age-related optic neuropathies. We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation. What evidence is there that we can reverse aging with drugs?

Science 145

Science Disease FDA Approval Pharmaceutical Companies 145

New Drug Approvals

JUNE 26, 2025

Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. 29 May 2025.

FDA 48

FDA Small Molecule Clinical Trials FDA Approval 48

New Drug Approvals

APRIL 30, 2025

1] [2] Levacetylleucine was approved for medical use in the United States in September 2024. [1] 1] [2] [3] Levacetylleucine is the second medication approved by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease type C. [2] 2] The FDA considers it to be a first-in-class medication. [4]

FDA 62

FDA FDA Approval Disease Trials 62

The Pharma Data

NOVEMBER 16, 2020

Earlier this year, Regeneron announced new global 2025 responsibility goals. ” Regeneron is dedicated to advancing our responsibility efforts. These goals span Regeneron’s three responsibility priority areas, focusing on the environmental and social topics that matter most to our stakeholders and business. .”

FDA Approval 52

FDA Approval Science Disease Laboratories 52