Pharmaceutical Technology

DECEMBER 1, 2022

Ferring Pharmaceuticals president Per Falk said: “This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development. The post US FDA approves Ferring’s Rebyota for Clostridioides difficile infection appeared first on Pharmaceutical Technology.

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FDA Approval Trials Clinical Development Drugs 264

Pharmaceutical Technology

MARCH 8, 2023

Shorla Oncology CEO and co-founder Sharon Cunningham said: “We are very proud to see our research in oncology innovation and dedication to patient care culminate in this US FDA approval. The post US FDA approves Shorla’s oncology drug for T-cell leukaemia appeared first on Pharmaceutical Technology.

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FDA Approval Drugs Production Development 246

Pharmaceutical Technology

MARCH 1, 2023

With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”

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FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

JUNE 9, 2023

Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE. Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks.

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FDA Approval Bioavailability Drugs Trials 246

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients.

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FDA Approval Medicine Drugs Trials 246

Pharmaceutical Technology

MARCH 10, 2023

The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.

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FDA Approval Gene Clinical Development Pharmacy 246

Fierce Pharma

NOVEMBER 16, 2023

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

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FDA Approval Drugs Marketing 126

Pharmaceutical Technology

MAY 29, 2023

Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”

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FDA Approval Trials Drugs Medicine 246

Pharmaceutical Technology

FEBRUARY 20, 2023

The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology. Vitreous floaters, ocular discomfort, conjunctival hemorrhage, and neovascular AMD were the most common adverse reactions observed in patients receiving Syfovre.

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FDA Approval Drugs Trials 246

Pharmaceutical Technology

SEPTEMBER 21, 2023

On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.

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FDA Approval Drugs 130

Pharmaceutical Technology

AUGUST 12, 2022

The latest development comes after Enhertu received FDA approval for treating unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The post US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer appeared first on Pharmaceutical Technology.

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FDA Approval Clinical Trials Clinical Trials Antibody 264

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. The regulatory approval represents the completion of the Cytogam technology transfer process from CSL Behring, its previous manufacturer.

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Pharmaceutical Technology

JANUARY 9, 2023

The post US FDA approves Eisai-Biogen’s antibody for Alzheimer’s appeared first on Pharmaceutical Technology. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial. The Amyloid-Related Imaging Abnormalities (ARIA) incidence profile of Leqembi was within expectations.

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FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharmaceutical Technology

FEBRUARY 2, 2023

The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology. Last December, GSK and Wave Life Sciences entered a strategic partnership to drive the discovery and development of oligonucleotide therapies for new genetic targets.

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FDA Approval Genetics Life Science Trials 264

Pharmaceutical Technology

APRIL 27, 2023

Seres president and CEO Eric Shaff said: “Seres has led the development of microbiome therapeutics, and today’s FDA approval of Vowst as the first orally administered microbiota-based therapeutic for the prevention of recurrent C difficile infection marks a tremendous milestone for the patient community, and for Seres.

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FDA Approval Drugs Trials Regulation 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

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FDA Approval Drugs Clinical Trials Clinical Trials 189

Pharmaceutical Technology

OCTOBER 2, 2023

Biogen’s Tofidence scores the US FDA approval for all arthritis indications similar to Roche’s Actemra (tocilizumab).

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FDA Approval 130

Pharmaceutical Technology

JULY 31, 2023

Harm Reduction Therapeutics won FDA approval for the second OTC naloxone nasal spray to treat known or suspected opioid overdose emergencies.

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FDA Approval 130

Pharmaceutical Technology

NOVEMBER 18, 2022

The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology. They received a 14-day course of either teplizumab or a placebo. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.

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FDA Approval Clinical Trials Clinical Trials Antibody 246

Fierce Pharma

NOVEMBER 20, 2023

Thanks to a new FDA approval, patients with ultra-rare desmoid tumors now have an FDA-approved treatment. Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.

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FDA Approval Drugs 85

Pharmaceutical Technology

AUGUST 29, 2023

Bristol Myers Squibb has received FDA approval for Reblozyl (luspatercept-aamt) as a first-line treatment for anaemia.

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FDA Approval 130

BioSpace

NOVEMBER 1, 2023

The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.

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FDA Approval Drugs 112

Pharmaceutical Technology

MARCH 13, 2023

Daybue is claimed to be the first and only drug to receive approval to treat Rett syndrome, a complex, rare neurodevelopmental disorder that affects 6,000 to 9,000 patients in the US. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

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FDA Approval Drugs Trials 182

Fierce Pharma

NOVEMBER 8, 2023

Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. |

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FDA Approval Drugs 129

Pharmaceutical Technology

SEPTEMBER 19, 2022

“For the ALD community, this long-awaited approval represents significant hope and offers families a new option where, for many, there had been none.”. The post FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy appeared first on Pharmaceutical Technology. thalassemia.

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FDA Approval Gene Therapy In-Vivo Clinical Trials 246

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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FDA Approval Genetics Trials Medicine 130

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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FDA Approval Bacteria Drugs Pharma Companies 130

Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). The post Lilly’s Jaypirca received FDA approval to treat MCL appeared first on Pharmaceutical Technology.

FDA Approval 147

FDA Approval Drugs Trials Development 147

Pharmaceutical Technology

FEBRUARY 3, 2023

It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation. The antibody has already been approved for the same indication in Japan, the EU, the US and other countries.

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FDA Approval Clinical Trials Clinical Trials Antibody 147

Pharmaceutical Technology

JUNE 12, 2023

It noted that the injection’s latest approval will help reduce the recent supply issues for the product in the country. This latest move marks Milla Pharmaceuticals’ second ‘first cycle’ FDA approval for an abbreviated new drug application (ANDA) and second paragraph IV filing.

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FDA Approval Drugs Production 130

Pharmaceutical Technology

MAY 23, 2023

Indivior CEO Mark Crossley said: “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids such as fentanyl.

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FDA Approval Drugs Trials Development 130

Pharmaceutical Technology

JULY 8, 2022

The post Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval appeared first on Pharmaceutical Technology. “From a patient perspective, this is the first time the women in the Philippines are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence.”.

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FDA Approval Drugs Clinical Trials Clinical Trials 246

Bio Pharma Dive

OCTOBER 23, 2023

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

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FDA Approval Vaccination Vaccine Sales 306

Pharmaceutical Technology

SEPTEMBER 30, 2022

These approvals represent crucial milestones for bluebird bio, the gene therapy field, and patients with rare genetic diseases. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.

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Gene Therapy FDA Approval Gene Genetic Disease 289

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The post Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis appeared first on Pharmaceutical Technology.

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FDA Approval Clinical Trials Clinical Trials Drugs 147

Pharmaceutical Technology

FEBRUARY 9, 2023

Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also for the family navigating a delicate time after preterm birth.

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FDA Approval Trials Drugs Development 130

BioSpace

SEPTEMBER 17, 2023

Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.

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FDA Approval 105