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

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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

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

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

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

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

Heron, on third attempt, secures FDA approval for non-opioid painkiller

Bio Pharma Dive

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

Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

Bio Pharma Dive

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.

CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

Pharma Mirror

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.

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

FDA approves Regeneron antibody drug as first Ebola virus treatment

Bio Pharma Dive

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19

Merck, Bayer win FDA approval for heart failure drug

Bio Pharma Dive

The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study

FDA Approves Novel Non-Stimulant Treatment for ADHD

BioSpace

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.

Recent FDA Approvals Target Zaire ebolavirus

Journal for Clinical Studies

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.

FDA approves injectable treatment for HIV patients

Outsourcing Pharma

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.

FDA Approves First Biologic for Rare, Debilitating Lung Disease

BioSpace

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.

Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot

Bio Pharma Dive

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

FDA Approves Third Sarepta Treatment For Duchenne Muscular Dystrophy

BioSpace

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.

Sarepta wins FDA approval of another drug for rare muscular dystrophy

Bio Pharma Dive

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

FDA approves Regeneron drug for rare, genetic form of high cholesterol

Bio Pharma Dive

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.

Akebia tries for FDA approval of anemia drug after mixed data

Bio Pharma Dive

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.

Long-acting HIV drug secures FDA approval, giving GSK a competitive boost

Bio Pharma Dive

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

AstraZeneca Celebrates a First as FDA Approves Farxiga for Chronic Kidney Disease

BioSpace

The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status

Genentech and Novartis Win FDA Approval for Self-Injectable Form of Xolair

BioSpace

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.

Janssen’s Simponi Aria Gains Extended FDA Approvals for Rare Children’s Arthritis Conditions

XTalks

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).

Altasciences Performs Phase I Studies for FDA Approval of Vibegron

BioTech 365

FDA Approvals Strengthen Octapharma USA Pediatric Critical Care Product Portfolio

BioTech 365

Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application

Bio Pharma Dive

While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response

FDA Approves NS Pharma’s Viltepso for Duchenne Muscular Dystrophy

BioSpace

Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen The U.S.

FDA Approves EndoClot® Hemostat to Manage GI Bleeding

BioTech 365

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

Pfizer Seeks Full F.D.A. Approval for Its Covid Vaccine

NY Times

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

Pfizer Seeks Full FDA Approval for Its Covid-19 Vaccine

NY Times

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

 FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

BioTech 365

FDA Approves First Acne Treatment with New Mechanism of Action in 40 Years

BioSpace

Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S.

Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

BioTech 365

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.

How COVID-19 is Changing FDA Approval and Clearance Processes

BioSpace

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.

Lantheus Holdings, Inc. Announces FDA Approval of DEFINITY® Room Temperature

BioTech 365

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.

FDA Approves GSK’s Checkpoint Inhibitor Jemperli for Endometrial Cancer

BioSpace

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

FDA approves first liquid biopsy test that uses advanced gene sequencing

Bio Pharma Dive

The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test

U.S. FDA Approves PANZYGA® for the Treatment of Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

BioTech 365

FDA Approves PANZYGA® for the Treatment of Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) U.S.

Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride in Water for Injection

BioTech 365

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

FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

The Pharma Data

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.