Efficacy and Safety Profile of Once-Daily Vemlidy Demonstrated in Children Six Years of Age (Weighing at Least 25kg) and Older FOSTER CITY, Calif. / Mar 28, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in... Read more
Once-Daily Oral HIF-PH Inhibitor Activates Physiologic Response to Manage Anemia
Akebia's Launch Strategy Developed to Drive Toward a Potential New Oral Standard of Care
Company to Host Conference Call on Thursday, March 28 at 8:00 AM ET CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the... Read more
The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access DUBLIN, March 27, 2024 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut... Read more
WINREVAIR is a breakthrough biologic for this rare, progressive disease
WINREVAIR on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone RAHWAY, N.J. / Mar 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name:... Read more
The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria
Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion
Roche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases Basel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)... Read more
Product references branded Ciprodex
Represents another complex, high value new product BRIDGEWATER, N.J. / Mar 25, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of ciprofloxacin, a fluoroquinolone... Read more
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+ NMOSD the potential to live relapse-free
Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how ULTOMIRIS may redefine patient journey for rare neurological disease WILMINGTON, Del. / Mar 25, 2024 / Business Wire / ULTOMIRIS® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment... Read more
New Labels Expand Treatable Population to ~70 Million Patients in U.S.
First LDL-C Lowering Non-Statin Indicated for Primary Prevention Patients
Approvals Based on Positive CLEAR Outcomes Data and Reflect a Highly Differentiated Product Profile
Positive CHMP Opinion Received; European Cardiovascular (CV) Risk Reduction Label Determination Anticipated in Q2 2024
Conference Call and Webcast on Monday, March 25 at 8:00 a.m. ET ANN ARBOR, Mich. / Mar 22, 2024 / Business... Read more
New Labels Expand Treatable Population to ~70 Million Patients in U.S.
First LDL-C Lowering Non-Statin Indicated for Primary Prevention Patients
Approvals Based on Positive CLEAR Outcomes Data and Reflect a Highly Differentiated Product Profile
Positive CHMP Opinion Received; European Cardiovascular (CV) Risk Reduction Label Determination Anticipated in Q2 2024
Conference Call and Webcast on Monday, March 25 at 8:00 a.m. ET ANN ARBOR, Mich., March 22, 2024 (GLOBE... Read more
The full approval of ELAHERE is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC)
Data show that ELAHERE treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35%
ELAHERE represents AbbVie's first approved solid tumor treatment following the recent acquisition of ImmunoGen NORTH... Read more
TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the U.S. Food and Drug Administration (FDA) has approved Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early... Read more
ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps
Clinical trial program also showed reduction in sinus inflammation and in acute exacerbations, which frequently result in use of antibiotics
XHANCE uses the proprietary Exhalation Delivery System to enable deposition of a proven steroid in target areas of inflammation deep in the... Read more
Breyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care
In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with median duration of CR not reached,... Read more
Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”)
Accelerated approval was based on Phase 3 data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis
Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis
Madrigal conference call scheduled for March 14, 2024, at 5:15... Read more
FDA approval based on MARCH Phase 3 study with highly statistically significant (p<0.0001) reduction in pruritus severity between LIVMARLI vs. placebo
Label covers broad range of PFIC subtypes
Immediate launch and availability for eligible patients in the U.S. FOSTER CITY, Calif. / Mar 13, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved LIVMARLI® (maralixibat) oral solution... Read more
TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH).
“Many children with heterozygous familial hypercholesterolemia (HeFH)... Read more
Bagsværd, Denmark, 8 March 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular... Read more
BRUKINSA is the first and only BTK inhibitor approved across five oncology indications and the first and only approved in follicular lymphoma
Approval based on positive results from ROSEWOOD trial showing BRUKINSA plus obinutuzumab achieved higher overall response rate versus obinutuzumab alone BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Mar 07, 2024 / Business Wire / BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today... Read more
THE FIRST AND ONLY HYALURONIC ACID DERMAL FILLER APPROVED FOR THE IMPROVEMENT OF MODERATE TO SEVERE TEMPLE HOLLOWING1 IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal... Read more
BEDFORD, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow® disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in... Read more
Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations
National Comprehensive Cancer Network ® (NCCN ®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) to recommend amivantamab-vmjw (RYBREVANT®) plus chemotherapy... Read more
First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.... Read more
SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S.
SIMLANDI is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the U.S. market
SIMLANDI will qualify for interchangeable exclusivity in the U.S. for some concentration strengths REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a... Read more
SCD-PED (Pediatric) is the first FDA-approved product in the Company’s Quelimmune™ product family DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic... Read more
Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory... Read more
Approval based on FLAURA2 results which showed TAGRISSO plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care WILMINGTON, Del. / Feb 16, 2024 / Business Wire / AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The... Read more
AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy
AMTAGVI deploys patient-specific immune cells that recognize and fight cancer SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell... Read more
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo
More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once
Detailed OUtMATCH results will be featured in a la... Read more
Masimo MightySat® Medical Provides Clinically Proven Masimo SET® Pulse Oximetry to Consumers for Medical Use Without a Prescription IRVINE, Calif. / Feb 13, 2024 / Business Wire / Masimo (NASDAQ: MASI) announced today FDA clearance of MightySat® Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available Over-The-Counter (OTC) direct to consumers without a prescription. All other pulse oximeters available at drug stores and online... Read more
12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older
EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing OSAKA, Japan & CAMBRIDGE, Mass. / Feb 12, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide... Read more