FDA approves new vitiligo treatment, bolstering Incyte's dermatology business

Bio Pharma Dive

The cream, known as Opzelura, is now the only treatment approved in the U.S. to repigment skin in patients with the most common form of vitiligo

Bluebird wins FDA approval of gene therapy for rare brain disorder

Bio Pharma Dive

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

Axsome rebounds to win FDA approval of depression drug

Bio Pharma Dive

A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up by as much as 40

FDA approves AstraZeneca, Daiichi drug in breast cancer first

Bio Pharma Dive

Enhertu is the first targeted treatment cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease

Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline

Daxxify, a New Anti-Wrinkle Drug and Botox Competitor is FDA-Approved

XTalks

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. The product has been approved for use in adult patients for the temporary improvement of moderate to severe glabellar (frown) lines.

Botox 83

Bristol Myers gets FDA approval for new type of psoriasis drug

Bio Pharma Dive

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company

Konvomep Gets FDA Approval as a New Oral Liquid Formulation Option of Omeprazole

XTalks

On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension).

FDA approves oral version of Mitsubishi's ALS drug

Bio Pharma Dive

Called Radicava ORS, this version is taken by mouth rather than via an hourlong infusion, which may help improve the drug's convenience and use

5 FDA approval decisions to watch in the first quarter

Bio Pharma Dive

The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug as well as mark the start of a price battle in oncology

5 FDA approval decisions to watch in the fourth quarter

Bio Pharma Dive

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

FDA Approval of Sanofi’s Enzyme Replacement Drug for ASMD + Disney Actress Partners with Medtronic for Diabetes Tech Campaign – Xtalks Life Science Podcast Ep. 77

XTalks

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients.

In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

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

Abbott’s Proclaim Plus Spinal Cord Stimulation System Clenches FDA Approval

XTalks

Yesterday, Abbott announced that their Proclaim Plus spinal cord stimulation system received approval from the US Food and Drug Administration (FDA). RELATED: NeuraLace’s Peripheral Nerve Stimulation System Wins FDA Clearance for Chronic Pain.

Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression

XTalks

Axsome Therapeutics’ extended-release tablets of Auvelity (dextromethorphan HBr -bupropion HCl) has been approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). The FDA granted Auvelity Breakthrough Therapy designation in March 2019.

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

XTalks

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions.

5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

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

FDA approves first CAR-T cell therapy for multiple myeloma

Bio Pharma Dive

Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma

In a first, FDA approves an 'interchangeable' biosimilar for diabetes

Bio Pharma Dive

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

Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

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

Seagen, Genmab win speedy FDA approval for cervical cancer drug

Bio Pharma Dive

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

5 FDA approval decisions to watch in the 1st quarter

Bio Pharma Dive

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

Takeda wins FDA approval for targeted lung cancer drug

Bio Pharma Dive

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

FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

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

Sanofi, after long research journey, wins FDA approval for rare disease drug

Bio Pharma Dive

Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi

5 FDA approval decisions to watch in the 4th quarter

Bio Pharma Dive

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

FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients.

Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow

Bio Pharma Dive

Converting Paxlovid’s emergency authorization to a standard clearance could further broaden its use. But the drug may not meaningfully help people who are vaccinated, and concerns about its potency against emerging variants are growing

FDA approves Lilly, Boehringer diabetes drug for heart failure

Bio Pharma Dive

The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

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

A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona

Fierce Pharma

A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona. Mon, 09/19/2022 - 10:21

Sotyktu (deucravacitinib) Gets FDA Approval for Moderate-to-Severe Plaque Psoriasis

XTalks

Last week, Bristol Myers Squibb (BMS) announced that their therapy Sotyktu (deucravacitinib) was approved by the US Food and Drug Administration (FDA) as a first-line treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

Bio Pharma Dive

The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch

Veklury Becomes the First FDA-Approved COVID-19 Treatment for Children Under 12

XTalks

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. This is the only approved COVID-19 treatment for children under 12 years of age.

With FDA approval, Axsome touts Auvelity as a potential game-changing depression treatment

Fierce Pharma

With FDA approval, Axsome touts Auvelity as a potential game-changing depression treatment. kdunleavy. Fri, 08/19/2022 - 11:01

GSK immunotherapy wins FDA approval, joining crowded cancer drug class

Bio Pharma Dive

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

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Bio Pharma Dive

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness

MacroGenics wins FDA approval of breast cancer drug

Bio Pharma Dive

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

Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect

Fierce Pharma

Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect. ntaylor. Fri, 09/02/2022 - 06:55

Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Bio Pharma Dive

Bristol Myers paid $13 billion to acquire the drug's maker, MyoKardia, and expects a top-selling medicine. But a tricky dosing regimen, as well as safety concerns, could challenge the pharmaceutical giant's lofty forecast

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

Pharma Phorum

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. .

US FDA approves Pfizer-BioNTech’s Covid-19 vaccine for adolescents

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years.

Roche wins FDA approval for rival to Regeneron's lucrative eye drug

Bio Pharma Dive

The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants