Stay up-to-date with the latest drug approvals by regulatory agencies worldwide. Gain insights into the regulatory processes, safety evaluations, and efficacy assessments. Stay informed about the new treatments available to patients and the impact they have on healthcare practices.

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 ...

Keytruda Wins FDA Nod for Biliary Cancer

FDA Approves Keytruda for Biliary Cancer, Rivals AstraZeneca’s Imfinzi

Anika Sharma

Merck’s Keytruda has received FDA approval to treat locally advanced unresectable or metastatic biliary tract cancer, alongside gemcitabine and cisplatin ...

Cosentyx Leads as New Biologic for Skin Condition

Novartis’ Cosentyx Clinches First Approval for Hidradenitis Suppurativa Treatment

Anika Sharma

Novartis’ Cosentyx has gained an early lead in the field of hidradenitis suppurativa (HS), a painful skin condition, potentially giving ...

Amgen Wins FDA Approval for Stelara Biosimilar

Amgen Secures FDA Approval for Stelara Biosimilar, Awaits 2025 Launch Post-Settlement

Anika Sharma

The FDA has granted approval to Amgen for its biosimilar rendition of Johnson & Johnson’s renowned autoimmune medication, Stelara. However, ...

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 ...

FDA Clearance for Micromate: The smallest robot for CT-guided biopsies

FDA Clearance for Micromate: A tiny robot that can perform needle biopsies with CT imaging

Anika Sharma

Interventional Systems, the brains behind a compact yet powerful robotic marvel, is set to leave a profound mark in the ...

Zilbrysq: UCB’s new antibody for myasthenia gravis

Zilbrysq, A Complement C5 Inhibitor For Myasthenia Gravis, Gets FDA Approval As UCB’s Second Drug For The Rare Disease

Anika Sharma

UCB is celebrating an impressive streak of FDA approvals, securing the green light for both the plaque psoriasis treatment Bimzelx ...

FDA approves Keytruda for lung cancer surgery

Keytruda approved by FDA for early-stage lung cancer surgery, with a twist

Anika Sharma

In a groundbreaking development, the FDA has granted approval for Merck’s Keytruda to be employed in a continuous immunotherapy regimen ...

Pfizer’s Velsipity gets FDA approval to challenge BMS’ Zeposia in ulcerative colitis market

Pfizer’s Velsipity gets FDA approval to challenge BMS’ Zeposia in ulcerative colitis market

Anika Sharma

Pfizer’s groundbreaking approval of its drug, Velsipity, as a once-daily oral treatment for adults suffering from moderate to severe active ...

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 ...

HistoSonics, histotripsy technology, liver cancer, de novo clearance, ultrasound

HistoSonics receives FDA approval for its ultrasound device that destroys liver tumors without surgery

Anika Sharma

In a groundbreaking move, the FDA has granted clearance to histotripsy technology, marking a significant milestone for HistoSonics and 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 ...

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 ...

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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 ...

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NICE approves Lilly’s Omvoh for ulcerative colitis after FDA rejection, citing cost-effectiveness and clinical benefits

Anika Sharma

“In a significant turn of events, Eli Lilly, despite initial setbacks in the US market with its ulcerative colitis drug ...

Sandoz biosimilar trastuzumab, EirGenix trastuzumab development, CHMP opinion trastuzumab, HER2-positive breast cancer, HER2-positive gastric cancer, EGC002 phase III study, , Sandoz oncology portfolio,

Sandoz gets CHMP nod for biosimilar of Herceptin, a drug for HER2+ breast and gastric cancer

Anika Sharma

Sandoz, a leading global player in generic and biosimilar medications, has received a noteworthy endorsement from the Committee for Medicinal ...

CHMP opinion, EMA approval, Daiichi Sankyo, Enhertu, Non-Small Cell Lung Cancer, HER2 Mutant NSCLC, DESTINY-Lung02 trial

Enhertu, a Breakthrough Therapy for HER2 Mutant NSCLC, Gets EU Nod

Anika Sharma

Enhertu (trastuzumab deruxtecan) has received a positive recommendation for approval in the European Union (EU) as a standalone treatment for ...

Quizartinib, CHMP opinion, FLT3-ITD Positive AML, EMA approval, acute myeloid leukemia, Daiichi Sankyo

Quizartinib Gets Green Light in EU for Treating Acute Myeloid Leukemia

Anika Sharma

Daiichi Sankyo has received a positive recommendation for the approval of quizartinib in the European Union (EU). This recommendation is ...

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 ...

robotic surgery, FDA, breast cancer, FDA clearance, Insight Medbotics, MRI machine

FDA approves world’s first MRI-compatible breast biopsy robot

Anika Sharma

Insight Medbotics has achieved FDA clearance for what it claims to be the world’s first surgical robot designed to operate ...

Zeta Surgical, FDA clearance, neurosurgery, navigation, Z-Map, brain surgery, GPS system

Zeta Surgical gets FDA clearance for its neurosurgery navigation system

Anika Sharma

Zeta Surgical is revolutionizing surgical precision with its newly FDA-cleared digital navigation system, designed to guide surgeons through complex brain ...

National Health Service, Eli Lilly, Mounjaro, National Institute for Health and Care Excellence, NICE recommendation, Type 2 diabetes

Eli Lilly’s Mounjaro gets NICE approval for type 2 diabetes after cost-effectiveness review

Anika Sharma

Eli Lilly’s diabetes medication, Mounjaro (tirzepatide), has been on a winning streak since its US launch in May, and now ...

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) ...

Tecentriq, Roche, Immunotherapy, PD-L1 inhibitor, lung cancer, bladder cancer, breast cancer, liver cancer

Tecentriq SC: A Swift Leap Forward in Cancer Treatment Receives Green Light

Anika Sharma

Roche has proudly unveiled that Tecentriq SC (atezolizumab) has received the stamp of approval from the Medicines and Healthcare products ...

Roche, EMA approval, spinal muscular atrophy, European Commission, Evrysdi

Roche’s Evrysdi Illuminates Hope: EC Expands Approval for SMA Infants

Anika Sharma

To provide a brighter future for infants battling spinal muscular atrophy (SMA), Roche has unveiled a momentous development. The European ...

Bristol Myers Squibb, luspatercept, Reblozyl, myelodysplastic syndromes, FDA approved, intermediate-risk myelodysplastic syndromes

FDA Grants Approval: Reblozyl’s Triumph Ushers in a New Dawn for Anemia Treatment

Anika Sharma

Bristol Myers Squibb has ushered in a breakthrough in the realm of medical advancements, announcing the FDA’s seal of approval ...

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 ...