Approvals
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
The FDA has granted clearance to Neurovalens’ Modius Sleep device, offering a novel, drug-free solution for chronic insomnia in the ...
Phathom Triumphs with Dual FDA Nods for GERD Therapy Voquezna
Phathom Pharmaceuticals has achieved rapid success with its innovative heartburn medication Voquezna (vonoprazan), securing two FDA approvals in just three ...
FDA Approves Keytruda for Biliary Cancer, Rivals AstraZeneca’s Imfinzi
Merck’s Keytruda has received FDA approval to treat locally advanced unresectable or metastatic biliary tract cancer, alongside gemcitabine and cisplatin ...
Novartis’ Cosentyx Clinches First Approval for Hidradenitis Suppurativa Treatment
Novartis’ Cosentyx has gained an early lead in the field of hidradenitis suppurativa (HS), a painful skin condition, potentially giving ...
Amgen Secures FDA Approval for Stelara Biosimilar, Awaits 2025 Launch Post-Settlement
The FDA has granted approval to Amgen for its biosimilar rendition of Johnson & Johnson’s renowned autoimmune medication, Stelara. However, ...
Pfizerās Penbraya: First vaccine to prevent all five types of meningitis gets FDA approval
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: A tiny robot that can perform needle biopsies with CT imaging
Interventional Systems, the brains behind a compact yet powerful robotic marvel, is set to leave a profound mark in the ...
Zilbrysq, A Complement C5 Inhibitor For Myasthenia Gravis, Gets FDA Approval As UCB’s Second Drug For The Rare Disease
UCB is celebrating an impressive streak of FDA approvals, securing the green light for both the plaque psoriasis treatment Bimzelx ...
Keytruda approved by FDA for early-stage lung cancer surgery, with a twist
In a groundbreaking development, the FDA has granted approval for Merck’s Keytruda to be employed in a continuous immunotherapy regimen ...
Pfizerās Velsipity gets FDA approval to challenge BMSā Zeposia in ulcerative colitis market
Pfizer’s groundbreaking approval of its drug, Velsipity, as a once-daily oral treatment for adults suffering from moderate to severe active ...
Pfizer gets FDA nod for Lorbrena-Vizimpro combo to treat advanced lung cancer
Pfizer is making strategic moves to reinforce its presence in the oncology arena, with the FDA granting approval for its ...
HistoSonics receives FDA approval for its ultrasound device that destroys liver tumors without surgery
In a groundbreaking move, the FDA has granted clearance to histotripsy technology, marking a significant milestone for HistoSonics and its ...
FDA Approves Biogenās Biosimilar, Challenging Rocheās Actemra Dominance in the Market
Biogen has achieved a remarkable milestone while contemplating the future of its biosimilars division. The company proudly announced that its ...
Viatris and Ocuphireās Ryzumvi gets FDA approval for reversing eye dilation
Viatris has achieved a significant milestone in its pursuit of reaching $1 billion in eye care sales by 2028. The ...
Jardiance gets FDA green light for chronic kidney disease, challenging AstraZenecaās rival drug
Shortly after securing European approval for the treatment of chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim have achieved ...
NICE approves Lillyās Omvoh for ulcerative colitis after FDA rejection, citing cost-effectiveness and clinical benefits
“In a significant turn of events, Eli Lilly, despite initial setbacks in the US market with its ulcerative colitis drug ...
Sandoz gets CHMP nod for biosimilar of Herceptin, a drug for HER2+ breast and gastric cancer
Sandoz, a leading global player in generic and biosimilar medications, has received a noteworthy endorsement from the Committee for Medicinal ...
Enhertu, a Breakthrough Therapy for HER2 Mutant NSCLC, Gets EU Nod
Enhertu (trastuzumab deruxtecan) has received a positive recommendation for approval in the European Union (EU) as a standalone treatment for ...
Quizartinib Gets Green Light in EU for Treating Acute Myeloid Leukemia
Daiichi Sankyo has received a positive recommendation for the approval of quizartinib in the European Union (EU). This recommendation is ...
FDA Approves Temodar (Temozolomide) Label Updates for Anaplastic Astrocytoma Treatment
In a significant development, the FDA has granted approval for temozolomide (marketed as Temodar) to be used as adjuvant therapy ...
FDA Approves Ojjaara (Momelotinib) for Treating High-Risk Myelofibrosis with Anemia a new competitor of Jakafi
The FDA has granted approval for momelotinib, marketed as Ojjaara, as a groundbreaking treatment option for adult patients grappling with ...
FDA approves Beacon Biosignalsā headset that uses AI to monitor and improve sleep quality
Beacon Biosignals has achieved an impressive milestone shortly after acquiring EEG headset manufacturer Dreem. The company has received FDA clearance ...
FDA approves worldās first MRI-compatible breast biopsy robot
Insight Medbotics has achieved FDA clearance for what it claims to be the world’s first surgical robot designed to operate ...
Zeta Surgical gets FDA clearance for its neurosurgery navigation system
Zeta Surgical is revolutionizing surgical precision with its newly FDA-cleared digital navigation system, designed to guide surgeons through complex brain ...
Eli Lillyās Mounjaro gets NICE approval for type 2 diabetes after cost-effectiveness review
Eli Lilly’s diabetes medication, Mounjaro (tirzepatide), has been on a winning streak since its US launch in May, and now ...
Mallinckrodt Launches New FDA-Approved ADHD Drug Lisdexamfetamine
Mallinckrodt, a global specialty pharmaceutical company, has made waves with an announcement that’s set to reshape the Attention-Deficit/Hyperactivity Disorder (ADHD) ...
Tecentriq SC: A Swift Leap Forward in Cancer Treatment Receives Green Light
Roche has proudly unveiled that Tecentriq SC (atezolizumab) has received the stamp of approval from the Medicines and Healthcare products ...
Roche’s Evrysdi Illuminates Hope: EC Expands Approval for SMA Infants
To provide a brighter future for infants battling spinal muscular atrophy (SMA), Roche has unveiled a momentous development. The European ...
FDA Grants Approval: Reblozyl’s Triumph Ushers in a New Dawn for Anemia Treatment
Bristol Myers Squibb has ushered in a breakthrough in the realm of medical advancements, announcing the FDA’s seal of approval ...
FDA Approves Novartis’ Tyruko: Revolutionizing MS Treatment Landscape Amidst Legal Drama
Stepping onto the stage with a flourish, Novartis has secured a resounding victory against Biogen in the realm of pharmaceutical ...
