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Avillion, AstraZeneca asthma rescue treatment given FDA approval

Pharma Phorum

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Commenting on the approval, Bradley E.

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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).

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Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

XTalks

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain. It is also pursuing a CE mark approval of the spinal cord stimulator in Europe.

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XBB.1.5 Omicron Subvariant + FDA Approves AstraZeneca’s New Asthma Inhaler – Xtalks Life Science Podcast Ep. 93

XTalks

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. AstraZeneca’s Airsupra Approved as First-In-Class Combo Asthma Treatment.

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Boostrix Gains FDA Approval as Prenatal Immunization to Prevent Whooping Cough in Newborns

XTalks

This week, GSK announced in a press release that the US Food and Drug Administration (FDA) had approved Boostrix as an immunization for pregnant women for the prevention of whooping cough in newborn infants. The evidence provided was sufficient to grant approval status.

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FDA Approves First Fecal Microbiota Product

The Pharma Data

FDA Approves First Fecal Microbiota Product. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. director of the FDA’s Center for Biologics Evaluation and Research.

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FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection

XTalks

Swiss company Ferring Pharmaceuticals has won a historic approval from the US Food and Drug Administration (FDA) for its fecal transplant-based therapy Rebyota (fecal microbiota, live-jslm) to reduce the recurrence of bacterial infection.

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RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval

The Pharma Data

RINVOQ is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) RINVOQ is the first and only JAK inhibitor approved for both active ankylosing spondylitis (AS) and nr-axSpA 1-3 In a clinical study, RINVOQ delivered rapid and meaningful disease control based on patients achieving ASAS40 vs. placebo, as well as significant improvement in signs and symptoms of nr-axSpA at week 14 1,2.

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AstraZeneca’s Airsupra Approved as First-In-Class Combo Asthma Treatment

XTalks

The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.

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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.

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GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer

XTalks

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer.

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US FDA approves BOOSTRIX for immunisation during gestation for the forestallment of whooping cough in invigorated babies

The Pharma Data

US FDA approves BOOSTRIX for immunisation during gestation for the forestallment of whooping cough in invigorated babies. Roger Connor, President, Vaccines and Global Health, GSK, said “ We ’re immensely proud to have the first- ever Tdap vaccine approved by the FDA specifically for this use during gestation. The tip caps of the prefilled hypes for BOOSTRIX contain natural rubber latex, which may beget antipathetic responses.

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FDA Approves First Virtual Reality Pain Treatment

XTalks

Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older.

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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.

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VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot

XTalks

VBI Vaccines got its first vaccine approval from the US Food and Drug Administration (FDA) for its hepatitis B shot PreHevbrio. PreHevbrio is approved for the prevention of hepatitis B infection caused by the hepatitis B virus (HBV) in adults 18 years of age and older.

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FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

The Pharma Data

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The FDA granted approval under the accelerated approval regulation.

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J&J files lung cancer bispecific amivantamab for FDA approval

Pharma Phorum

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

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FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

The Pharma Data

Food and Drug Administration approved Boostrix( Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed( Tdap)) for immunization during the third trimester of gestation to help pertussis, generally known as whooping cough, in babies youngish than two months of age.

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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

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Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

XTalks

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. As such, unresectable or metastatic uveal melanoma usually has a poor prognosis and until the approval of Kimmtrak, there was no approved treatment.

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FDA Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19. The nursing home industry applauded the approval. SATURDAY, Dec.

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FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

The Pharma Data

Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By The U.S.

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Imaging Drug Cytalux (pafolacianine) Approved for Detection of Lung Cancer During Surgery

XTalks

has obtained US Food and Drug Administration (FDA) approval of an expanded indication for the use of Cytalux (pafolacianine) for the detection of lung cancer during surgery. On Target Laboratories, Inc.

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FDA approves opioid Olinvyk for patients with acute pain

The Pharma Data

The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work.

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FDA approval to Keytruda and Lenvima; FibroGen’s Roxadustat; Pfizer’s TICOVAC; Ipsen’s Palovarotene; Jazz Pharma’s Xywav; Seagen-RemeGen’s Cancer Medicine

Delveinsight

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

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U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

The Pharma Data

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S.

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FDA approves GSK’s Blenrep for advanced multiple myeloma

Pharma Phorum

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on.

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Regeneron’s Inmazeb named Galien’s Best Biotech Product

Pharma Phorum

It is the first FDA-approved treatment for Zaire ebolavirus. These mice contain the “full repertoire” of human heavy chain immunoglobulin genes and kappa light chain genes, each linked to the endogenous mouse constant regions.

Gene 52
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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”. The FDA, an agency within the U.S.

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Breyanzi (lisocabtagene maraleucel) Gets FDA Approval for Relapsed or Refractory LBCL After One Prior Therapy

XTalks

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. These are expanded indications after the FDA’s first approval of Breyanzi back in February 2021.

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FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

The Pharma Data

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp.

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FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

The Pharma Data

KEYTRUDA Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation. This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community.

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GSK’s Injectable HIV Treatment Cabenuva Garners FDA Approval

XTalks

GlaxoSmithKline’s (GSK) ViiV Healthcare — which focuses on HIV treatments and prevention — has received approval from the US Food and Drug Administration (FDA) for its highly anticipated injectable HIV treatment.

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First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation

XTalks

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. FDA Assessment of the Harmony Pulmonary Valve.

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FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ?4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)

The Pharma Data

Approval based on KEYNOTE-091 trial, which demonstrated a clinically meaningful improvement in disease-free survival with KEYTRUDA in these patients following surgical resection and platinum-based chemotherapy versus placebo Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. In NSCLC, KEYTRUDA has five approved U.S.

HR 40
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FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. With this approval, the FDA issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Eiger. Food and Drug Administration (FDA).

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FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps

The Pharma Data

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. and in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps.

Insulin 52
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U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children

The Pharma Data

Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four-dose series and superior immune responses for important disease-causing shared serotype 3 and unique serotypes 22F and 33F compared to PCV13.

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Yale-NBA Partnership Results in FDA Approval for COVID-19 SalivaDirect Test

XTalks

SalivaDirect, a saliva-based COVID-19 test that was tested among players of the National Basketball Association (NBA), has been given emergency use authorization (EUA) by the US Food and Drug Administration (FDA). And now it’s getting approval.

Reagent 77
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FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm.

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GSK’s Boostrix for pertussis cleared by FDA for use in pregnancy

Pharma Phorum

The FDA has approved use of GlaxoSmithKline’s Boostrix (Tdap) vaccine for use during the third trimester of pregnancy, for prevention of pertussis (whooping cough) in infants younger than two months old.

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FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y.,

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.