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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
By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment MORE
The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months. internal-essential Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc MORE
Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S. MORE
Announces FDA Approval of DEFINITY® Room Temperature Lantheus Holdings, Inc. Announces FDA Approval of DEFINITY® Room Temperature Commercially Available in Early 2021 NORTH BILLERICA, Mass.–(BUSINESS Lantheus Holdings, Inc. MORE
52 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
96 
Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution MORE
FDA Approves PANZYGA® for the Treatment of Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) U.S. MORE
52 
The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025. MORE
The biotech set an average annual price of $450,000 for the first-of-its-kind drug, which treats a condition that affects about 1,300 people in the U.S. MORE
While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response MORE
135 FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD The U.S. MORE
94 Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company The U.S. MORE
Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride in Water for Injection Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride in Water for Injection LINCOLNSHIRE, Ill.–(BUSINESS MORE
The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months. internal-essential Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc MORE
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test MORE
The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020 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
A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June MORE
Rather than a once-a-day pill, Cabenuva comes as a once-a-month injection. That convenience could become a valuable tool for GSK as it tries to broaden adoption of two-drug treatments MORE
The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study MORE
That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain The drugmaker's pill fell short on a critical safety measure in two large trials last fall. MORE
Jemperli is the seventh drug cleared by the FDA that blocks either PD-1 or PD-L1 proteins, joining Merck's Keytruda, Bristol Myers' Opdivo and others MORE
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S. MORE
Margenza, which bested Roche's Herceptin in a head-to-head study, offers a new option to patients with HER2-positive metastatic breast cancer who have already tried other regimens MORE
The approval was specifically for patients with recurrent or advanced endometrial cancer who had progressed on or after previous treatment with platinum-based chemotherapy and whose cancers have a dMMR genetic anomaly MORE
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma MORE
284 
Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19 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 regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status MORE
81 
FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. MORE
109 Two drugs recently approved by the US Food and Drug Administration (FDA) treat disease caused by the Zaire ebolavirus, one… The post Recent FDA Approvals Target Zaire ebolavirus appeared first on Journal for Clinical Studies. MORE
Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) EMPAVELI, the … Continue reading → GlobeNewswireApellis Announces U.S. MORE
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year MORE
The agency has given the thumbs up to ViiVâs once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV. MORE
FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping The U.S. MORE
94 
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
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). . New approvals. Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose. MORE
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors MORE
283 
Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed MORE
FDA Approves EndoClot® Hemostat to Manage GI Bleeding FDA Approves EndoClot® Hemostat to Manage GI Bleeding A Unique Product to Rapidly and Reliably Control Bleeding During GI Procedures SANTA CLARA, Calif.–(BUSINESS MORE
FDA Approval Related Topics 
Bio Pharma Dive
MARCH 29, 2021
A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June
Bio Pharma Dive
MARCH 27, 2021
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma
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Bio Pharma Dive
FEBRUARY 5, 2021
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors
Bio Pharma Dive
JANUARY 5, 2021
By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment
Bio Pharma Dive
JANUARY 25, 2021
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year
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
Bio Pharma Dive
MAY 13, 2021
The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020
Bio Pharma Dive
MAY 7, 2021
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.
Pharma Mirror
MARCH 10, 2021
The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.
Bio Pharma Dive
DECEMBER 17, 2020
Margenza, which bested Roche's Herceptin in a head-to-head study, offers a new option to patients with HER2-positive metastatic breast cancer who have already tried other regimens
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
Bio Pharma Dive
JANUARY 20, 2021
The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study
BioSpace
APRIL 4, 2021
FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S.
Journal for Clinical Studies
APRIL 26, 2021
Two drugs recently approved by the US Food and Drug Administration (FDA) treat disease caused by the Zaire ebolavirus, one… The post Recent FDA Approvals Target Zaire ebolavirus appeared first on Journal for Clinical Studies.
Outsourcing Pharma
JANUARY 25, 2021
The agency has given the thumbs up to ViiVâs once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV.
BioSpace
MARCH 4, 2021
FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD The U.S.
Bio Pharma Dive
FEBRUARY 19, 2021
Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution
BioSpace
FEBRUARY 25, 2021
FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping The U.S.
Bio Pharma Dive
FEBRUARY 25, 2021
Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed
Bio Pharma Dive
FEBRUARY 12, 2021
The biotech set an average annual price of $450,000 for the first-of-its-kind drug, which treats a condition that affects about 1,300 people in the U.S.
Bio Pharma Dive
MARCH 30, 2021
That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain The drugmaker's pill fell short on a critical safety measure in two large trials last fall.
Bio Pharma Dive
JANUARY 22, 2021
Rather than a once-a-day pill, Cabenuva comes as a once-a-month injection. That convenience could become a valuable tool for GSK as it tries to broaden adoption of two-drug treatments
BioSpace
MAY 2, 2021
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status
BioSpace
APRIL 12, 2021
Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company The U.S.
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).
BioTech 365
MARCH 29, 2021
Bio Pharma Dive
APRIL 9, 2021
While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response
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.
BioTech 365
FEBRUARY 23, 2021
FDA Approves EndoClot® Hemostat to Manage GI Bleeding FDA Approves EndoClot® Hemostat to Manage GI Bleeding A Unique Product to Rapidly and Reliably Control Bleeding During GI Procedures SANTA CLARA, Calif.–(BUSINESS
NY Times
MAY 7, 2021
The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months. internal-essential Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc
NY Times
MAY 7, 2021
The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months. internal-essential Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc
BioTech 365
APRIL 12, 2021
BioSpace
AUGUST 26, 2020
Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S.
BioTech 365
MAY 14, 2021
Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) EMPAVELI, the … Continue reading → GlobeNewswireApellis Announces U.S.
BioSpace
AUGUST 31, 2020
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.
BioTech 365
NOVEMBER 18, 2020
Announces FDA Approval of DEFINITY® Room Temperature Lantheus Holdings, Inc. Announces FDA Approval of DEFINITY® Room Temperature Commercially Available in Early 2021 NORTH BILLERICA, Mass.–(BUSINESS Lantheus Holdings, Inc.
BioSpace
APRIL 21, 2021
The approval was specifically for patients with recurrent or advanced endometrial cancer who had progressed on or after previous treatment with platinum-based chemotherapy and whose cancers have a dMMR genetic anomaly
Bio Pharma Dive
AUGUST 10, 2020
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test
BioTech 365
FEBRUARY 12, 2021
FDA Approves PANZYGA® for the Treatment of Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) U.S.
BioTech 365
MARCH 25, 2021
Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride in Water for Injection Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride in Water for Injection LINCOLNSHIRE, Ill.–(BUSINESS
The Pharma Data
MAY 5, 2021
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). . New approvals. Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose.
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