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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
FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis – LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition … Continue reading → Business Wire MORE
40 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 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
100 
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 first shots could be given as early as Dec. 21, if authorization is granted. 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 approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients … Continue reading → GlobeNewswire MORE
40 Food and Drug Administration (FDA) approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy The U.S. MORE
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency. Source link. MORE
52 
Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC) Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC) Companion diagnostic can help guide treatment decisions in cases of … Continue reading → Business Wire MORE
52 
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
Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago. MORE
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test MORE
FDA approves Xolair® (omalizumab) for adults with nasal polyps FDA approves Xolair® (omalizumab) for adults with nasal polyps Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of … Continue reading → GlobeNewswire MORE
40 
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V. your-feed-science Acquired Immune Deficiency Syndrome Drugs (Pharmaceuticals) Food and Drug Administration United States 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
“It’s important that Impulse Dynamics acted quickly in a joint effort with the FDA to remove this potential barrier standing in the way of critical diagnostic procedures for a subset of patients with HF. 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
Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning The U.S. 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
First therapy approved for the ultra-rare and progressive condition MORE
76 
The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. 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
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
are expected to be approved by the U.S. FDA this year. as a treatment for metastatic breast cancer, under priority review by FDA are about to announce the results of their BLA/NDA approval (biologics license application; BLA), respectively. FDA approval this year. MORE
This approval marks the first treatment indicated for reducing mortality risk in patients with the rare disorder known as molybdenum cofactor deficiency (MoCD) Type A MORE
63 
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
Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps – Xolair is the first biologic for the treatment of nasal polyps that targets and blocks … Continue reading → Business Wire MORE
52 
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
Food and Drug Administration (FDA) approval for Succinylcholine Chloride Injection, USP in 200mg/10mL Multiple-Dose Vials. LINCOLNSHIRE, Ill.–(BUSINESS –(BUSINESS WIRE)–Nexus Pharmaceuticals announced it has received U.S. 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
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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
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
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
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
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
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.
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.
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
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
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.
BioTech 365
FEBRUARY 12, 2021
FDA Approves PANZYGA® for the Treatment of Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) U.S.
BioTech 365
FEBRUARY 22, 2021
Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC) Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC) Companion diagnostic can help guide treatment decisions in cases of … Continue reading → Business Wire
NY Times
JANUARY 21, 2021
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V. your-feed-science Acquired Immune Deficiency Syndrome Drugs (Pharmaceuticals) Food and Drug Administration United States
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
AUGUST 26, 2020
Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S.
Pharma Times
MARCH 1, 2021
First therapy approved for the ultra-rare and progressive condition
Pharma Times
DECEMBER 23, 2020
Ebanga approved to treat Ebola in adult and paediatric patients
Bio Pharma Dive
AUGUST 10, 2020
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test
BioSpace
FEBRUARY 14, 2021
Food and Drug Administration (FDA) approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy The U.S.
NY Times
NOVEMBER 30, 2020
The first shots could be given as early as Dec. 21, if authorization is granted.
BioTech 365
FEBRUARY 9, 2021
FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients … Continue reading → GlobeNewswire
Pharmacy Checkers
NOVEMBER 12, 2020
The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs.
BioTech 365
OCTOBER 29, 2020
Food and Drug Administration (FDA) approval for Succinylcholine Chloride Injection, USP in 200mg/10mL Multiple-Dose Vials. LINCOLNSHIRE, Ill.–(BUSINESS –(BUSINESS WIRE)–Nexus Pharmaceuticals announced it has received U.S.
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.
The Pharma Data
JANUARY 18, 2021
“It’s important that Impulse Dynamics acted quickly in a joint effort with the FDA to remove this potential barrier standing in the way of critical diagnostic procedures for a subset of patients with HF.
BioTech 365
DECEMBER 1, 2020
FDA approves Xolair® (omalizumab) for adults with nasal polyps FDA approves Xolair® (omalizumab) for adults with nasal polyps Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of … Continue reading → GlobeNewswire
BioSpace
FEBRUARY 28, 2021
This approval marks the first treatment indicated for reducing mortality risk in patients with the rare disorder known as molybdenum cofactor deficiency (MoCD) Type A
BioTech 365
JANUARY 22, 2021
FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis – LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition … Continue reading → Business Wire
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
The Pharma Data
NOVEMBER 29, 2020
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency. Source link.
BioSpace
JANUARY 19, 2021
Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning The U.S.
The Pharma Data
JANUARY 17, 2021
are expected to be approved by the U.S. FDA this year. as a treatment for metastatic breast cancer, under priority review by FDA are about to announce the results of their BLA/NDA approval (biologics license application; BLA), respectively. FDA approval this year.
BioTech 365
DECEMBER 1, 2020
Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps – Xolair is the first biologic for the treatment of nasal polyps that targets and blocks … Continue reading → Business Wire
Pharma Phorum
JANUARY 21, 2021
Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago.
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