XTalks

OCTOBER 30, 2024

Shorla Oncology recently received US Food and Drug Administration (FDA) approval to expand Jylamvo ’s (methotrexate) use for children with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis. This highlights Shorla’s ongoing focus on simplifying medication prep and dosing.

FDA Approval 110

FDA Approval Drugs Clinical Trials Clinical Trials 110

XTalks

AUGUST 23, 2023

BriaCell recently received FDA approval for its Bria-IMT Combination pivotal study design in advanced metastatic breast cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 98

Life Science Clinical Trials Clinical Trials FDA Approval 98

XTalks

NOVEMBER 14, 2024

PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency.

Gene Therapy 105

Gene Therapy FDA Approval Gene Clinical Trials 105

XTalks

MAY 5, 2022

Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. The US Food and Drug Administration (FDA) has approved two classes of drugs for the treatment of ADHD: stimulants and nonstimulants.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JANUARY 2, 2024

Chiesi Global Rare Diseases, a specialized division within the Chiesi Group dedicated to pioneering therapies for individuals affected by rare diseases, has received approval from the US Food and Drug Administration (FDA) for Filsuvez (birch triterpenes) topical gel.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

XTalks

MAY 2, 2022

Mycovia Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for Vivjoa (oteseconazole) for the treatment of recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection for permanently infertile or postmenopausal women. In the global VIOLET studies, 93.3 percent and 96.1 percent and 60.6

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

NOVEMBER 28, 2023

Kesin Pharma has obtained approval from the US Food and Drug Administration (FDA) for its oral suspension antibiotic drug Likmez (metronidazole), designed for patients with dysphagia and difficulty swallowing. Likmez offers a safer alternative by mitigating the associated risks linked to off-label drug compounding.

FDA Approval 103

FDA Approval Bacteria DNA Drugs 103

XTalks

OCTOBER 22, 2024

Astellas Pharma has won approval from the US Food and Drug Administration (FDA) for Vyloy (zolbetuximab) as a first-line treatment for adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The drug is specifically indicated for patients whose tumors are HER2-negative and express claudin 18.2

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

XTalks

DECEMBER 18, 2023

Merck received its second US Food and Drug Administration (FDA) approval for its cancer pill Welireg (belzutifan). In the statement, Merck said Welireg’s approval for advanced renal cell carcinoma makes it the first drug in its class approved for the disease and the first in a novel therapeutic class since 2015.

FDA Approval 98

FDA Approval Drugs Sales Medicine 98

XTalks

APRIL 21, 2023

And in 2015 the US Food & Drug Administration (FDA) approved an assay on Theranos’ proprietary technology.” Life science startups face unique challenges given the highly regulated and complex nature of the industry. Outsiders who reviewed the technology said it worked.

Life Science 98

Life Science Trials Production Regulation 98

XTalks

MARCH 9, 2023

Travere Therapeutics recently announced that their medication Filspari (sparsentan) received accelerated approval from the US Food and Drug Administration (FDA). The approval was granted for its use as a non-immunosuppressive therapy for the reduction of proteinuria (protein in urine) in IgA nephropathy in adults.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

Botox 98

Botox FDA Approval Cosmetics Clinical Trials 98

World of DTC Marketing

JANUARY 24, 2022

Venture capitalists have poured $42 billion into drug development over the past three years. Most small biotech companies rely on venture capitalist funding to develop new drugs but is that a good way to go? billion, which was much lower than previous studies, which have placed the average cost of drug development as $2.8

Life Science 225

Life Science Drugs Development Genetic Disease 225

XTalks

MARCH 3, 2022

Developed in partnership with Legend Biotech Corp of China, Johnson & Johnson’s cell therapy Carvykti (formerly known as cilta-cel) received approval from the US Food and Drug Administration (FDA) this week for the treatment of multiple myeloma. Live and On-Demand: March 16, 2022 | 9am EDT (NA) / 1pm GMT (UK).

FDA Approval 98

FDA Approval Life Science Production Trials 98

XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 The FDA approved 2.5

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The drug generated domestic sales of $200.4 million last year, of which $131.3

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

FDA Law Blog

JUNE 27, 2023

Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. Karst Awarded WWL: Life Sciences 2023 Global Elite Thought Leader HP&M Director Kurt R.

Life Science 81

Life Science FDA Approval Drugs Development 81

XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

XTalks

AUGUST 12, 2024

The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) as the first non-needle emergency treatment of allergic reactions (Type I), including life-threatening ones like anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds.

FDA Approval 105

FDA Approval Allergies Production Drugs 105

XTalks

APRIL 3, 2024

The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).

FDA Approval 102

FDA Approval Sales Trials Development 102

XTalks

OCTOBER 16, 2024

Pfizer’s Hympavzi (marstacimab-hncq) has received approval from the US Food and Drug Administration (FDA) for treating hemophilia A or B in adults and adolescents aged 12 and older with factor VIII deficiency (hemophilia A) or factor IX deficiency (hemophilia B), who do not have inhibitors to these factors.

FDA Approval 105

FDA Approval Trials Clinical Trials Clinical Trials 105

XTalks

FEBRUARY 26, 2024

The US Food and Drug Administration (FDA) has granted expanded approval to Genentech’s (part of Roche) Xolair (omalizumab) to help reduce allergic reactions to various foods after accidental exposure.

Allergies 100

Allergies FDA Approval Drugs Protein 100

XTalks

OCTOBER 25, 2022

Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo’s approval was based on results from the HIMALAYA Phase III trial , which showed that patients treated with the Imjudo and Imfinzi combination experienced a 22 percent reduction in the risk of death versus sorafenib.

FDA Approval 98

FDA Approval Trials Drugs Immune Response 98

XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

FDA Approval 95

FDA Approval Bacteria Trials Protein 95

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). John’s University College of Pharmacy & Health Sciences, Queens, New York.

FDA Approval 98

FDA Approval Containment Pharmacy Medicine 98

XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Production 98

XTalks

JUNE 21, 2024

The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older. Additional data from the Phase III STRIDE-4 and STRIDE-6 studies, which assessed Capvaxive in vaccine-naïve and vaccine-experienced adults, also helped seal the approval.

FDA Approval 108

FDA Approval Vaccination Vaccine Life Science 108

XTalks

DECEMBER 18, 2024

The US Food and Drug Administration (FDA) has granted approval to Checkpoint Therapeutics PD-L1 inhibitor Unloxcyt (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients who cannot be cured with surgery or radiation therapy.

FDA Approval 95

FDA Approval Antibody Immune Response Marketing 95

XTalks

SEPTEMBER 12, 2022

After approvals in Japan and Europe, Sanofi’s Xenpozyme has secured one from the US Food and Drug Administration (FDA) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.

FDA Approval 98

FDA Approval Genetics Trials Gene 98

XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

FDA Approval 98

FDA Approval Antibody Drugs Protein 98

XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). anthracis exposure.

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

XTalks

NOVEMBER 7, 2024

Galderma’s doxycycline drug Oracea (doxycycline 40 mg capsules) is the current standard-of-care treatment for rosacea. Emrosi’s approval was based on data from a pair of Phase III clinical trials for the treatment of rosacea. Other studies suggest that Helicobacter pylori bacteria infections may also cause rosacea.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. How Does Ycanth Work? ’s berdazimer gel, containing 10.3

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

XTalks

OCTOBER 4, 2022

The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

JULY 14, 2022

Rare and rheumatic disease-focused biotech Horizon Therapeutics has received expanded approval from the US Food and Drug Administration (FDA) for its gout injection Krystexxa (pegloticase) to include its co-administration with the immunomodulator methotrexate. It is the first and only biologic approved for the condition.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105