Bio Pharma Dive

JULY 19, 2022

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

Dermatology 267

Dermatology FDA Approval 267

Bio Pharma Dive

SEPTEMBER 16, 2022

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

Gene Therapy 282

Gene Therapy FDA Approval Gene Production 282

Bio Pharma Dive

AUGUST 19, 2022

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 Approval 224

FDA Approval Regulation Drugs 224

Bio Pharma Dive

AUGUST 5, 2022

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

FDA Approval 236

FDA Approval Doctors Doctor Drugs 236

Bio Pharma Dive

MAY 13, 2022

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

FDA Approval 279

FDA Approval Branding Drugs 279

XTalks

SEPTEMBER 14, 2022

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

Botox FDA Approval Cosmetics Clinical Trials 83

Bio Pharma Dive

SEPTEMBER 10, 2022

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

FDA Approval 241

FDA Approval Drugs 241

XTalks

SEPTEMBER 6, 2022

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 Approval 83

FDA Approval Pharmacy Containment Doctors 83

Bio Pharma Dive

MAY 13, 2022

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

FDA Approval 224

FDA Approval Drugs 224

Bio Pharma Dive

JANUARY 5, 2022

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

FDA Approval 258

FDA Approval Drugs 258

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

FDA Approval 263

FDA Approval Regulation Vaccination Vaccine 263

XTalks

SEPTEMBER 14, 2022

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.

FDA Approval 77

FDA Approval Life Science Clinical Trials Clinical Trials 77

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

FDA Approval 284

FDA Approval Gene Scientist Drugs 284

XTalks

AUGUST 24, 2022

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.

FDA Approval 82

FDA Approval Clinical Trials Clinical Trials Engineer 82

XTalks

AUGUST 22, 2022

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.

FDA Approval 82

FDA Approval Sales Production Manufacturing 82

XTalks

AUGUST 19, 2022

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.

Gene Therapy 81

Gene Therapy FDA Approval Gene Clinical Trials 81

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

FDA Approval 284

FDA Approval Vaccination Vaccine Drugs 284

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

FDA Approval 284

FDA Approval 284

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

FDA Approval 259

FDA Approval Insulin Production Marketing 259

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

FDA Approval 283

FDA Approval 283

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

FDA Approval 235

FDA Approval Antibody Marketing Medicine 235

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

FDA Approval 282

FDA Approval Drugs 282

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

FDA Approval 231

FDA Approval Gene Marketing Drugs 231

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

FDA Approval 265

FDA Approval Development Drugs 265

Bio Pharma Dive

SEPTEMBER 1, 2022

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

FDA Approval 181

FDA Approval Research Drugs 181

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

FDA Approval 279

FDA Approval Antibody Vaccination Vaccine 279

Pharmaceutical Technology

SEPTEMBER 19, 2022

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.

FDA Approval 73

FDA Approval Gene Therapy Gene Licensing 73

Bio Pharma Dive

JUNE 30, 2022

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 Approval 223

FDA Approval Vaccination Vaccine Drugs 223

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

FDA Approval 216

FDA Approval Sales Drugs 216

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

FDA Approval 265

FDA Approval Regulation Drugs 265

Fierce Pharma

SEPTEMBER 19, 2022

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

Gene Therapy 87

Gene Therapy FDA Approval Gene 87

XTalks

SEPTEMBER 16, 2022

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 Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Bio Pharma Dive

JUNE 14, 2022

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

FDA Approval 216

FDA Approval Drugs 216

XTalks

APRIL 27, 2022

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.

FDA Approval 83

FDA Approval In-Vitro Vaccination Vaccine 83

Fierce Pharma

AUGUST 19, 2022

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

FDA Approval 99

FDA Approval 99

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

FDA Approval 216

FDA Approval Protein Drugs 216

Bio Pharma Dive

DECEMBER 22, 2021

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

FDA Approval 272

FDA Approval Sales Doctors Doctor 272

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

FDA Approval 231

FDA Approval Drugs 231

Fierce Pharma

SEPTEMBER 2, 2022

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

FDA Approval 87

FDA Approval 87

Bio Pharma Dive

APRIL 28, 2022

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 Approval 224

FDA Approval Medicine Drugs 224

Pharma Phorum

FEBRUARY 25, 2022

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. .

FDA Approval 84

FDA Approval HR Cardiology Drugs 84

Pharmaceutical Technology

JULY 11, 2022

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.

FDA Approval 86

FDA Approval Licensing Licensing Antibody 86

Bio Pharma Dive

JANUARY 31, 2022

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

FDA Approval 241

FDA Approval Drugs 241