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Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen The U.S. MORE
Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder The U.S. MORE
-ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children -Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020 DEER PARK, Ill., MORE
Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), it has emerged. MORE
Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S. MORE
It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis. MORE
The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA Approval & Clearance. MORE
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Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). NEW YORK–(BUSINESS WIRE)–Pfizer Inc. MORE
This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2 MORE
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a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. This is the first approval under the previously announced collaboration between Nevakar and Endo for the development of five differentiated, sterile injectable products in the U.S. BRIDGEWATER, N.J., MORE
Food and Drug Administration (FDA) has approved Regeneronâs Inmazeb for treatment of Ebola. The U.S. The antibody cocktail was developed using the same ârapid responseâ technologies as Regeneronâs investigational COVID-19 antibody combination. Bio Developments MORE
Medical University of South Carolina clinician-innovators targeted the problem of needle-stick injuries during intraoperative monitoring; their invention, a safer needle, is now FDA approved and licensed to Rhythmlink for rollout this fall in hospitals Credit: Photograph by Joshua Aaron Photography, provided by Rhythmlink. MORE
The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May MORE
The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work. MORE
The FDA has announced its approval of GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES). . This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. Photo by Maxwell Hamilton. MORE
Enspryng is the second drug OK'd in three months for an autoimmune disorder that causes blindness and impaired mobility, but it's the only one that patients can take at home MORE
– First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks – – First and only approved therapy for NMOSD designed to target … Continue reading → Business Wire MORE
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test MORE
Photo by the CDC/FDA. The FDA has approved a new indication of Trelegy Ellipta for the treatment of asthma and patients with chronic obstructive pulmonary disease. . MORE
The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda MORE
– First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks – – First and only approved therapy for NMOSD designed to target … Continue reading → Business Wire MORE
Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. MORE
The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. This approval is supported by results from two randomised controlled phase 3 trials, the SAkuraStar and SAkuraSky studies. MORE
Bristol-Myers Squibb’s immunotherapy combination of Opdivo and Yervoy has been approved in the US in a new indication for untreated mesothelioma, a rare but aggressive form of cancer that forms in the lining of the lungs. MORE
The FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Japan’s NS Pharma takes on Sarepta and its controversially approved rival. The post NS Pharma takes on Sarepta as FDA approves DMD drug appeared first on. MORE
FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. MORE
today announced that it has received approval from the U.S. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Foundation Medicine, Inc. MORE
Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19 MORE
Simplify Disc overall success rate of 93.0% was superior to the ACDF control SUNNYVALE, Calif., 21, 2020 (GLOBE NEWSWIRE) — Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, … Continue reading → GlobeNewswire MORE
regulator granted a full approval after allowing emergency use earlier this year. The U.S. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness MORE
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. MORE
Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older. MORE
The FDA has given emergency clearance for Abbott’s portable COVID-19 test that it will sell for just $5. . The company’s BinaxNOW COVID-19 Ag Card test can give results within 15 minutes and is designed to be administered in places like schools and workplaces to carry out mass testing. MORE
Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., MORE
First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 … Continue reading → GlobeNewswire MORE
Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour. MORE
The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA). MORE
The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. Air Force photo by Kemberly Groue. It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment. MORE
announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay. RESEARCH TRIANGLE PARK, N.C.–(BUSINESS –(BUSINESS WIRE)–Avioq, Inc. The HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation … Continue reading → Business Wire MORE
Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour MORE
FDA Approval Related Topics 
Bio Pharma Dive
OCTOBER 22, 2020
regulator granted a full approval after allowing emergency use earlier this year. The U.S. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness
Bio Pharma Dive
SEPTEMBER 29, 2020
The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda
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Bio Pharma Dive
OCTOBER 14, 2020
Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19
XTalks
OCTOBER 6, 2020
The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA).
BioSpace
AUGUST 12, 2020
Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen The U.S.
BioSpace
AUGUST 26, 2020
Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S.
Bio Pharma Dive
AUGUST 10, 2020
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test
The Pharma Data
OCTOBER 22, 2020
FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization.
Pharma Phorum
AUGUST 21, 2020
It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.
NY Times
OCTOBER 22, 2020
The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May
Bio Pharma Dive
AUGUST 17, 2020
Enspryng is the second drug OK'd in three months for an autoimmune disorder that causes blindness and impaired mobility, but it's the only one that patients can take at home
BioTech 365
AUGUST 14, 2020
– First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks – – First and only approved therapy for NMOSD designed to target … Continue reading → Business Wire
BioSpace
AUGUST 16, 2020
Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder The U.S.
The Pharma Data
SEPTEMBER 7, 2020
Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), it has emerged.
The Pharma Data
AUGUST 4, 2020
Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour.
The Pharma Data
SEPTEMBER 28, 2020
The FDA has announced its approval of GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES). . This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. Photo by Maxwell Hamilton.
BioTech 365
OCTOBER 22, 2020
announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay. RESEARCH TRIANGLE PARK, N.C.–(BUSINESS –(BUSINESS WIRE)–Avioq, Inc. The HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation … Continue reading → Business Wire
BioTech 365
OCTOBER 23, 2020
today announced that it has received approval from the U.S. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Foundation Medicine, Inc.
Pharma Times
AUGUST 4, 2020
Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour
BioTech 365
AUGUST 15, 2020
– First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks – – First and only approved therapy for NMOSD designed to target … Continue reading → Business Wire
Scienmag
AUGUST 5, 2020
Medical University of South Carolina clinician-innovators targeted the problem of needle-stick injuries during intraoperative monitoring; their invention, a safer needle, is now FDA approved and licensed to Rhythmlink for rollout this fall in hospitals Credit: Photograph by Joshua Aaron Photography, provided by Rhythmlink.
BioTech 365
SEPTEMBER 28, 2020
Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). NEW YORK–(BUSINESS WIRE)–Pfizer Inc.
The Pharma Data
SEPTEMBER 10, 2020
Photo by the CDC/FDA. The FDA has approved a new indication of Trelegy Ellipta for the treatment of asthma and patients with chronic obstructive pulmonary disease. .
Pharma Phorum
AUGUST 6, 2020
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on.
BioSpace
SEPTEMBER 1, 2020
This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2
The Pharma Data
AUGUST 27, 2020
The FDA has given emergency clearance for Abbott’s portable COVID-19 test that it will sell for just $5. . The company’s BinaxNOW COVID-19 Ag Card test can give results within 15 minutes and is designed to be administered in places like schools and workplaces to carry out mass testing.
Pharma Phorum
AUGUST 10, 2020
Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.
The Pharma Data
OCTOBER 14, 2020
Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y.,
The Pharma Data
AUGUST 24, 2020
The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. Air Force photo by Kemberly Groue. It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment.
Pharma Phorum
AUGUST 17, 2020
The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. This approval is supported by results from two randomised controlled phase 3 trials, the SAkuraStar and SAkuraSky studies.
The Pharma Data
AUGUST 10, 2020
The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work.
The Pharma Data
AUGUST 27, 2020
Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.
The Pharma Data
OCTOBER 21, 2020
a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. This is the first approval under the previously announced collaboration between Nevakar and Endo for the development of five differentiated, sterile injectable products in the U.S. BRIDGEWATER, N.J.,
BioTech 365
OCTOBER 16, 2020
BioTech 365
SEPTEMBER 21, 2020
Simplify Disc overall success rate of 93.0% was superior to the ACDF control SUNNYVALE, Calif., 21, 2020 (GLOBE NEWSWIRE) — Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, … Continue reading → GlobeNewswire
BioTech 365
AUGUST 16, 2020
First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 … Continue reading → GlobeNewswire
BioTech 365
SEPTEMBER 29, 2020
-ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children -Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020 DEER PARK, Ill.,
BioPharma Reporter
OCTOBER 15, 2020
Food and Drug Administration (FDA) has approved Regeneronâs Inmazeb for treatment of Ebola. The U.S. The antibody cocktail was developed using the same ârapid responseâ technologies as Regeneronâs investigational COVID-19 antibody combination. Bio Developments
Pharma Phorum
OCTOBER 5, 2020
Bristol-Myers Squibb’s immunotherapy combination of Opdivo and Yervoy has been approved in the US in a new indication for untreated mesothelioma, a rare but aggressive form of cancer that forms in the lining of the lungs.
Pharma Phorum
AUGUST 13, 2020
The FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Japan’s NS Pharma takes on Sarepta and its controversially approved rival. The post NS Pharma takes on Sarepta as FDA approves DMD drug appeared first on.
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