FDA APPROVAL

FDA Approves Neurovalens' Modius Sleep Headset for Insomnia

FDA Approves Neurovalens’ Modius Sleep Headset for Insomnia

Anika Sharma

The FDA has granted clearance to Neurovalens’ Modius Sleep device, offering a novel, drug-free solution for chronic insomnia in the ...

Voquezna Wins FDA Approval, GERD Game Changer

Phathom Triumphs with Dual FDA Nods for GERD Therapy Voquezna

Anika Sharma

Phathom Pharmaceuticals has achieved rapid success with its innovative heartburn medication Voquezna (vonoprazan), securing two FDA approvals in just three ...

Pfizer’s 5-in-1 meningitis vaccine approved by FDA

Pfizer’s Penbraya: First vaccine to prevent all five types of meningitis gets FDA approval

Anika Sharma

Pfizer has secured a significant regulatory victory in the race to introduce the first five-pronged meningitis vaccine in the United ...

Pfizer wins FDA approval for lung cancer combo

Pfizer gets FDA nod for Lorbrena-Vizimpro combo to treat advanced lung cancer

Anika Sharma

Pfizer is making strategic moves to reinforce its presence in the oncology arena, with the FDA granting approval for its ...

Biogen, Roche, Actemra, biosimilars, FDA approval, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, tofidence

FDA Approves Biogen’s Biosimilar, Challenging Roche’s Actemra Dominance in the Market

Anika Sharma

Biogen has achieved a remarkable milestone while contemplating the future of its biosimilars division. The company proudly announced that its ...

Invitae gets FDA approval for blood test that detects hereditary cancer genes

Invitae gets FDA approval for blood test that detects hereditary cancer genes

Anika Sharma

Invitae has achieved a significant milestone with the FDA granting de novo clearance for its groundbreaking blood test. This test ...

Viatris and Ocuphire’s Ryzumvi gets FDA approval for reversing eye dilation

Viatris and Ocuphire’s Ryzumvi gets FDA approval for reversing eye dilation

Anika Sharma

Viatris has achieved a significant milestone in its pursuit of reaching $1 billion in eye care sales by 2028. The ...

jardiance chronic kidney disease fda approval, lilly boehringer jardiance kidney disease, jardiance vs farxiga kidney disease, jardiance kidney disease trial results, jardiance kidney disease indication, jardiance kidney disease benefits, jardiance kidney disease market

Jardiance gets FDA green light for chronic kidney disease, challenging AstraZeneca’s rival drug

Anika Sharma

Shortly after securing European approval for the treatment of chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim have achieved ...

Temozolomide, Anaplastic Astrocytoma, Temodar, FDA approval, glioblastoma

FDA Approves Temodar (Temozolomide) Label Updates for Anaplastic Astrocytoma Treatment

Anika Sharma

In a significant development, the FDA has granted approval for temozolomide (marketed as Temodar) to be used as adjuvant therapy ...

GlaxoSmithKline, momelotinib, Ojjaara, FDA approval, myelofibrosis, MOMENTUM trial, SIMPLIFY-1 trial, intermediate or high-risk myelofibrosis

FDA Approves Ojjaara (Momelotinib) for Treating High-Risk Myelofibrosis with Anemia a new competitor of Jakafi

Anika Sharma

The FDA has granted approval for momelotinib, marketed as Ojjaara, as a groundbreaking treatment option for adult patients grappling with ...

Beacon Biosignals, FDA approval, neurological disorders, Artificial Intelligence

FDA approves Beacon Biosignals’ headset that uses AI to monitor and improve sleep quality

Anika Sharma

Beacon Biosignals has achieved an impressive milestone shortly after acquiring EEG headset manufacturer Dreem. The company has received FDA clearance ...

Mallinckrodt, Lisdexamfetamine, ADHD, aNDA, Lisdexamfetamine Dimesylate Capsules, FDA approval

Mallinckrodt Launches New FDA-Approved ADHD Drug Lisdexamfetamine

Anika Sharma

Mallinckrodt, a global specialty pharmaceutical company, has made waves with an announcement that’s set to reshape the Attention-Deficit/Hyperactivity Disorder (ADHD) ...

Novartis, Biogen, Biosimilar, Tysabri, FDA Approval, Sandoz, Tyruko

FDA Approves Novartis’ Tyruko: Revolutionizing MS Treatment Landscape Amidst Legal Drama

Anika Sharma

Stepping onto the stage with a flourish, Novartis has secured a resounding victory against Biogen in the realm of pharmaceutical ...

CAR T-cell therapy, blood cancer treatment, immunotherapy, personalized targeting, breakthrough, benefits, risks, approved therapies, leukemia, lymphoma, multiple myeloma,

CAR T-Cell Therapy in Hematological Malignancies: A Breakthrough or a Bust?

Anika Sharma

Hematological malignancies are cancers that affect the blood, bone marrow, and lymph nodes. They include leukemia, lymphoma, and multiple myeloma. ...

Neurocrine Biosciences, FDA Approval, Ingrezza, Huntington’s Disease, Valbenazine

FDA Approves Ingrezza (valbenazine) Capsules to Treat Chorea in Huntington’s Disease

Anika Sharma

Neurocrine Biosciences has achieved a significant milestone with the announcement of US Food and Drug Administration (FDA) approval for Ingrezza ...

Veopoz, Regeneron Pharmaceuticals, CHAPLE disease, FDA approval, Enteropathy

FDA Grants Landmark Approval to Veopoz for the Treatment of Pediatric and Adult CHAPLE Disease

Anika Sharma

On August 18, 2023, Regeneron Pharmaceuticals announced a remarkable milestone. The US Food and Drug Administration (FDA) has granted approval ...

Eylea, Regeneron Pharmaceuticals, Wet Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, FDA approval

FDA Approves Eylea HD Injection 8 mg for the Treatment of Wet Age-related Macular Degeneration, Diabetic Macular Edema, and Diabetic Retinopathy

Anika Sharma

On August 18, 2023, Regeneron Pharmaceuticals announced a groundbreaking development in the field of ophthalmology: the US Food and Drug ...

Forxiga, Chronic heart failure, Dapagliflozin, FDA approval, National Medical Products Administration

Forxiga Receives Green Light in China to Mitigate Cardiovascular Mortality and Hospitalization in Adults Battling Symptomatic Chronic Heart Failure

Anika Sharma

China’s National Medical Products Administration (NMPA) has granted approval to Forxiga (dapagliflozin) as a groundbreaking solution in the fight against ...

Ipsen, Clementia, FDA, Roche, Pharma, rare diseases, FDA approval, Sohonos

FDA Grants Approval to Ipsen’s Sohonos Capsules, the First-Ever Treatment for Individuals with Fibrodysplasia Ossificans Progressiva

Anika Sharma

In 2019, Ipsen made a significant investment of $1 billion to acquire Clementia Pharmaceuticals and its rare disease drug, palovarotene. ...

Hepzato Kit, Delcath, Eye cancer, FDA approval, Uveal Melanoma

Delcath Triumphs After Years: FDA Grants Approval to Hepzato Kit for Treating Metastatic Uveal Melanoma

SG Tylor

After enduring nearly a decade of setbacks, Delcath has finally achieved a regulatory milestone in the United States. Delaware-based Delcath ...

Revance, FDA, Daxxify, Cervical dystonia, FDA Approval

Revance into Therapeutic Realm with FDA Approval for Cervical Dystonia Treatment, Daxxify

SG Tylor

Revance, a prominent player in the aesthetics market, has now made a strategic move into the promising therapeutic arena. Following ...

FDA Approves J&J’s Akeega for Prostate Cancer Treatment

Johnson & Johnson Breaks Into Prostate Cancer Market with Akeega

SG Tylor

After the FDA’s green light for AstraZeneca/Merck and Pfizer’s PARP inhibitors, Johnson & Johnson (J&J) has now secured its own ...

Amylyx Pharmaceuticals Shines with ALS Drug's Relyvrio's Strong Performance and Promising Path Forward

Amylyx Pharmaceuticals Shines with ALS Drug’s Relyvrio’s Strong Performance and Promising Path Forward

SG Tylor

Amylyx Pharmaceuticals continues to impress the financial world with its amyotrophic lateral sclerosis (ALS) drug, Relyvrio. The medication, known by ...

FDA to Approve Eylea’s Breakthrough Dose for Diabetic Eye Disease

Regeneron’s High-Dose Eylea Demonstrates Persistence as FDA Decision Looms

SG Tylor

While awaiting an FDA decision regarding a higher-dose version of Eylea (aflibercept), Regeneron has consistently emphasized the durability of their ...

Johnson & Johnson, Talvey, FDA, Multiple myeloma, FDA Approval, Talquetamab

Johnson & Johnson Takes Lead in Bispecific Antibody Approval for Multiple Myeloma, Leaving Pfizer in the Dust

SG Tylor

The FDA has granted accelerated approval to talquetamab-tgvs, branded as Talvey, for treating relapsed or refractory multiple myeloma in adults ...

IZERVAY: FDA Approves First Drug for Geographic Atrophy

FDA Approves Izervay for Geographic Atrophy

SG Tylor

Source – Astellas Pharma Astellas Pharma has received FDA approval for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic ...

Epcoritamab Receives FDA Approval – A Game-Changer in Cancer Treatment

FDA Grants Approval to Epcoritamab– Redefining the Future of DLBCL

SG Tylor

In the world of cancer treatment, groundbreaking advancements are constantly being made, offering new hope for patients and their loved ...

FDA sets the stage for adcomm on Sanofi, AZ's RSV prospect later this week

FDA sets the stage for adcomm on Sanofi, AZ’s RSV prospect later this week

SG Tylor

GSK and Pfizer have plans to introduce their adult respiratory syncytial virus (RSV) vaccines later this year, while Sanofi and ...

Pfizer Emerges as Key Player in RSV Vaccine Market with FDA Approval for ABRYSVO, Impacts Market Dynamics

Pfizer’s RSV Vaccine ABRYSVO: A Breakthrough for the Industry and RSV Prevention

SG Tylor

Pfizer’s RSV Vaccine: In a groundbreaking development, Pfizer’s FDA approval for its RSV vaccine, ABRYSVO, has not only positioned the ...

Indivior Receives FDA Approval for OPVEE (nalmefene)

Indivior Receives FDA Approval for OPVEE (nalmefene)

SG Tylor

Indivior’s OPVEE® (nalmefene) nasal spray has received FDA approval for the emergency treatment of opioid overdose in adults and pediatric ...

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