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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
Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older. MORE
Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows. MORE
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally MORE
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
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 
Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it MORE
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019 MORE
The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects MORE
FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis FDA Approval Based on Positive Results of International, Multi-center ProDERM Study PARAMUS, N.J.–(BUSINESS MORE
The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however MORE
The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency MORE
Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease MORE
First and only FDA-approved treatment for the neurological sleep disorder MORE
87 
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
This week, the U.S. Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development MORE
Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 Enables expansion of recruitment into ongoing phase I study to include eligible US patients … Continue reading → Business Wire MORE
Yesterday saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar drug. Markets & Regulations 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
Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too 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
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 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
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
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective 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
First targeted treatment authorised in the US for NSCLC patients with EGFR exon 20 insertion mutations MORE
82 The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. MORE
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 Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine MORE
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives 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
Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely 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 An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs 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 The agency's decision makes available a new treatment option for patients with advanced systemic mastocytosis, boosting the biotech in the process MORE
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
The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance MORE
FDA Approval Related Topics 
Bio Pharma Dive
OCTOBER 1, 2021
Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too
Bio Pharma Dive
SEPTEMBER 21, 2021
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019
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Bio Pharma Dive
MAY 28, 2021
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective
Bio Pharma Dive
JULY 29, 2021
An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs
Bio Pharma Dive
SEPTEMBER 16, 2021
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally
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
Bio Pharma Dive
AUGUST 19, 2021
The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance
Bio Pharma Dive
NOVEMBER 18, 2021
Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely
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
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
OCTOBER 14, 2021
The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however
|
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
APRIL 23, 2021
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
Bio Pharma Dive
SEPTEMBER 20, 2021
The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency
Bio Pharma Dive
AUGUST 2, 2021
The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects
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
JUNE 7, 2021
With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives
BioPharma Reporter
JULY 29, 2021
Yesterday saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar drug. Markets & Regulations
Pharma Times
AUGUST 13, 2021
First and only FDA-approved treatment for the neurological sleep disorder
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.
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
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
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
JUNE 7, 2021
Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine
Bio Pharma Dive
JUNE 8, 2021
Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it
BioTech 365
NOVEMBER 29, 2021
Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 Enables expansion of recruitment into ongoing phase I study to include eligible US patients … Continue reading → Business Wire
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
JUNE 17, 2021
The agency's decision makes available a new treatment option for patients with advanced systemic mastocytosis, boosting the biotech in the process
BioSpace
NOVEMBER 2, 2021
This week, the U.S. Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development
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.
Pharma Phorum
JUNE 3, 2021
The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market.
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
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.
Bio Pharma Dive
MAY 17, 2021
Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease
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
Pharma Phorum
OCTOBER 25, 2021
Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows.
BioTech 365
JULY 20, 2021
FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis FDA Approval Based on Positive Results of International, Multi-center ProDERM Study PARAMUS, N.J.–(BUSINESS
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.
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.
Pharma Times
MAY 24, 2021
First targeted treatment authorised in the US for NSCLC patients with EGFR exon 20 insertion mutations
XTalks
NOVEMBER 22, 2021
Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older.
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