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Chimerix

Companies That Recently Received FDA Approval

Company
Last Trade
Change
Volume
Shares Out
Market Cap
US$ 777.96
-0.22 -0.03
2.94M
950.16M
US$ 739.190B
US$ 128.40
0.35 0.27
3.49M
4.46B
US$ 572.660B
US$ 158.19
0.23 0.15
5.13M
2.41B
US$ 381.240B
US$ 131.95
0.20 0.15
8.79M
2.53B
US$ 333.830B
US$ 182.10
1.75 0.97
4.95M
1.77B
US$ 322.320B
US$ 581.21
1.84 0.32
922,628
381.31M
US$ 221.620B
US$ 67.75
-0.51 -0.75
3.42M
3.10B
US$ 210.020B
US$ 31.92
0.61 1.95
1.77M
6.38B
US$ 203.650B
US$ 113.66
0.18 0.16
4.50M
1.74B
US$ 197.770B
US$ 96.73
0.85 0.89
1.51M
2.04B
US$ 197.330B
US$ 27.75
-0.03 -0.11
37.95M
5.66B
US$ 157.060B
US$ 284.32
-1.98 -0.69
2.28M
535.92M
US$ 152.370B
US$ 399.09
-1.01 -0.25
1.09M
354.45M
US$ 141.460B
US$ 357.87
-0.84 -0.23
934,520
380.26M
US$ 136.080B
US$ 87.15
0.23 0.26
6.80M
1.33B
US$ 115.910B
US$ 54.23
0.98 1.84
12.46M
2.02B
US$ 109.540B
US$ 418.01
0.69 0.17
1.05M
258.31M
US$ 107.980B
US$ 962.49
-3.81 -0.39
446,659
107.94M
US$ 103.890B
US$ 68.49
-0.13 -0.19
6.00M
1.47B
US$ 100.680B
US$ 73.25
0.24 0.33
8.24M
1.25B
US$ 91.560B
US$ 42.87
-0.12 -0.28
1.85M
2.04B
US$ 87.450B
US$ 169.21
0.70 0.42
3.20M
457.87M
US$ 77.480B
US$ 247.45
0.92 0.37
994,158
288.90M
US$ 71.490B
US$ 13.89
-0.30 -2.11
1.48M
3.14B
US$ 43.610B
US$ 145.51
-1.86 -1.26
1.84M
293.06M
US$ 42.640B
US$ 90.91
0.60 0.66
1.77M
455.36M
US$ 41.400B
US$ 215.63
-0.71 -0.33
1.76M
145.36M
US$ 31.340B
US$ 393.72
-4.87 -1.22
184,199
59.30M
US$ 23.350B
US$ 29.91
-0.72 -2.35
355,483
652.57M
US$ 19.520B
US$ 10.75
-0.19 -1.74
295,563
1.79B
US$ 19.240B
US$ 77.96
0.61 0.79
1.62M
234.73M
US$ 18.300B
US$ 87.34
-1.27 -1.43
928,414
188.68M
US$ 16.480B
US$ 156.39
1.31 0.84
101,621
104.43M
US$ 16.330B
US$ 14.11
-0.32 -2.22
10.21M
1.12B
US$ 15.800B
US$ 11.94
0.11 0.93
11.46M
1.19B
US$ 14.210B
US$ 137.92
0.09 0.07
1.20M
99.51M
US$ 13.720B
US$ 56.97
-0.15 -0.26
1.76M
224.53M
US$ 12.790B
US$ 129.46
-0.77 -0.59
771,176
93.86M
US$ 12.150B
US$ 226.17
2.30 1.03
273,543
47.06M
US$ 10.640B
US$ 42.99
0.24 0.56
1.04M
221.36M
US$ 9.520B
US$ 16.28
0.11 0.68
2.19M
492.97M
US$ 8.030B
US$ 146.85
2.37 1.64
599,524
52.91M
US$ 7.770B
US$ 23.73
-0.13 -0.54
2.05M
303.19M
US$ 7.190B
US$ 58.78
0.29 0.50
1.22M
120.58M
US$ 7.090B
US$ 214.79
1.29 0.60
609,045
30.30M
US$ 6.510B
US$ 43.35
-1.31 -2.93
1.90M
145.75M
US$ 6.320B
US$ 17.30
0.09 0.52
356,996
350.99M
US$ 6.070B
US$ 53.64
0.58 1.09
691,783
112.94M
US$ 6.060B
US$ 94.86
0.07 0.07
602,986
61.23M
US$ 5.810B
US$ 267.04
8.23 3.18
435,650
20.65M
US$ 5.510B

Recent FDA Approval News


FDA Expands Indication for Gilead's Vemlidy (Tenofovir Alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six

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


Akebia Therapeutics Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

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


Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis

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


FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)

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


Roche receives FDA approval for the first molecular test to screen for malaria in blood donors

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



AstraZeneca: ULTOMIRIS® (ravulizumab-cwvz) approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD)

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


U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin...

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


Esperion: U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin...

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


AbbVie: U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients

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


Orchard Therapeutics Receives FDA Approval of Lenmeldy™ (atidarsagene autotemcel), the Only Therapy for Eligible Children with Early-onset Metachromatic Leukodystrophy in the U.S.

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


OptiNose: XHANCE Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

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


U.S. FDA Approves Bristol Myers Squibb’s Breyanzi® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (

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


Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosi

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


Mirum Pharmaceuticals’ LIVMARLI Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis

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


Regeneron Pharmaceuticals: Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol

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


Novo Nordisk: Wegovy® approved in the US for cardiovascular risk reduction in people with overweight or obesity and established cardiovascular disease

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


BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma

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


AbbVie: Juvéderm® VOLUMA® XC For Temple Hollows Receives U.S. FDA Approval

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


Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients

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


RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutat

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


Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon

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


Alvotech and Teva Pharmaceuticals Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

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


FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury

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


Johnson & Johnson: TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma

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


AstraZeneca: TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

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


Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

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


FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

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 Announces First FDA-cleared “Over-the-Counter” Fingertip Pulse Oximeter

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


FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE)

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

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