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

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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

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 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 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

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 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.

Altasciences Performs Phase I Studies for FDA Approval of Vibegron

BioTech 365

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.

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

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

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).

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.

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.

Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC)

BioTech 365

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

F.D.A. Approves Monthly Shots to Treat H.I.V.

NY Times

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

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 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.

FDA approves Nulibry to treat Molybdenum Cofactor Deficiency Type A

Pharma Times

First therapy approved for the ultra-rare and progressive condition

Ridgeback Biotherapeutics’ Ebola treatment scores FDA approval

Pharma Times

Ebanga approved to treat Ebola in adult and paediatric patients

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

FDA Approves G1 Therapeutics' Cosela to Prevent Chemo Damage in Lung Cancer

BioSpace

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.

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Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

NY Times

The first shots could be given as early as Dec. 21, if authorization is granted.

FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma

BioTech 365

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

New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

Pharmacy Checkers

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.

Nexus Pharmaceuticals Receives FDA Approval for Succinylcholine Chloride Injection, USP

BioTech 365

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.

Mission successful for Novartis after FDA approves ofatumumab in MS

Pharma Phorum

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.

Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

The Pharma Data

“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.

FDA approves Xolair® (omalizumab) for adults with nasal polyps

BioTech 365

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

FDA Approves BridgeBio Affiliate’s Therapy for Rare Metabolic Disease

BioSpace

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

FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis

BioTech 365

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

Roche wins FDA approval for 1st self-administered biologic for rare eye disease

Bio Pharma Dive

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

FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

BioTech 365

Rhythm Receives FDA Approval for IMCIVREE in Certain Patients with Obesity

The Pharma Data

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.

Merck and Bayer Win FDA Approval for Heart Failure Drug

BioSpace

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.

Hanmi Pharmaceutical expects U.S. FDA approval for 2 new drugs

The Pharma Data

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.

Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps

BioTech 365

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

FDA approves Bayer/Merck & Co heart failure drug

Pharma Phorum

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.