FDA and Pharmaceutical - Pharma Rep Focus

ARS Pharmaceuticals hit with surprise FDA rejection of Neffy, its nasal spray epinephrine alternative

Fierce Pharma

SEPTEMBER 20, 2023

Positive FDA advisory committee votes aren’t always a blueprint for approval. Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.

FDA

FDA Pharmaceutical

House lawmaker brings FDA into biosecurity crackdown on China

Fierce Pharma

MAY 8, 2024

In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States. Amid a U.S. |

FDA

FDA Pharmaceutical

Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Fierce Pharma

APRIL 3, 2024

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

FDA

FDA Pharmaceutical

Vertex, CRISPR's gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

Fierce Pharma

JANUARY 16, 2024

Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FD | Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT).

FDA

FDA Pharmaceutical

FDA rejects Defender Pharma's motion sickness nasal gel candidate

Fierce Pharma

JANUARY 30, 2024

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. |

FDA

FDA Pharma Pharmaceutical

FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

APRIL 10, 2024

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

FDA

FDA Manufacturing Pharmaceutical products Healthcare

Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week.

FDA

FDA Pharmaceutical

X4 enters commercial fold with FDA approval of rare disease drug Xolremdi

Fierce Pharma

APRIL 29, 2024

With the approval of X4 Pharmaceuticals’ first product mavorixafor, there’s a new commercial rare disease player in town. Following a 10-year development journey, the FDA on Monday approved X4 Pharmaceuticals’ Xolremdi.

FDA

FDA Pharmaceutical Patients

5 years after initial FDA rejection, Lexicon prepares to resubmit Type 1 diabetes hopeful Zynquista

Fierce Pharma

MARCH 11, 2024

Ever since its first FDA rejection five years ago, Lexicon Pharmaceuticals hasn’t given up hope on its Type 1 diabetes prospect sotagliflozin. | The company hopes its long and bumpy five-year journey will soon see an end with an FDA approval. Lexicon looks to resubmit the drug by the middle of the year.

FDA

FDA Prospecting Pharmaceutical

After buying Novan's assets, Ligand crosses FDA finish line with molluscum gel Zelsuvmi

Fierce Pharma

JANUARY 7, 2024

Less than six months after Ligand Pharmaceuticals swooped in to buy Novan’s assets following the latter company’s bankruptcy, the purchase has paid off with an FDA approval. | Less than six months after Ligand Pharmaceuticals swooped in to buy Novan’s assets following the latter company’s bankruptcy, the purchase has paid off with an FDA approval. (..)

FDA

FDA Pharmaceutical

After Formosa snags FDA nod for reformulation of old steroid, partner Eyenovia plots launch

Fierce Pharma

MARCH 5, 2024

Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid. | Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid. With that, the company's U.S.

FDA

FDA Pharmaceutical

Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback

Fierce Pharma

NOVEMBER 2, 2023

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). | In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna.

FDA

FDA Pharmaceutical

FDA approves X4 Pharmaceuticals’ WHIM syndrome drug

Pharmaceutical Technology

APRIL 30, 2024

The US FDA has approved X4 Pharmaceuticals' XOLREMDI (mavorixafor) capsules for patients aged 12 and above with WHIM syndrome.

Pharmaceutical

Pharmaceutical FDA Patients

Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Fierce Pharma

DECEMBER 8, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. Groundbreaking? Game-changing? Transformational?

FDA

FDA Medicine Pharmaceutical

After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat

Fierce Pharma

OCTOBER 12, 2023

Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partn | The FDA shot down Alvotech and Teva's biosimilar candidate to Johnson & Johnson's Stelara over “certain deficiencies” uncovered by the FDA (..)

FDA

FDA Manufacturing Pharmaceutical

After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma

Fierce Pharma

SEPTEMBER 26, 2023

It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent (..)

FDA

FDA Pharmaceutical Patients

Look out, Teva. Neurocrine's Ingrezza wins Huntington's disease FDA nod to rival Austedo

Fierce Pharma

AUGUST 22, 2023

With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease.

FDA

FDA Pharmaceutical

Jazz brings the noise to the FDA with lawsuit over approval of Avadel's narcolepsy drug Lumryx

Fierce Pharma

JUNE 23, 2023

After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.

FDA

FDA Competition Pharmaceutical

FDA clears Tarsus' Xdemvy as first treatment for common eyelid disease

Fierce Pharma

JULY 25, 2023

Patients with the eyelid disease Demodex blepharitis can now see a cure in Tarsus Pharmaceuticals’ Xdemvy, the first FDA-approved treatment for an ailment that affects some 25 million Americans.

FDA

FDA Pharmaceutical Patients

Intas analyst poured acid over manufacturing docs, FDA says in scathing warning letter

Fierce Pharma

AUGUST 2, 2023

Intas Pharmaceuticals’ new warning letter from the U.S. FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022.

Manufacturing

Manufacturing FDA Pharmaceutical

US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

Food and Drug Administration

Food and Drug Administration Pharmaceutical FDA Food

Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing

Fierce Pharma

NOVEMBER 30, 2023

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. | It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing.

Pharmaceutical manufacturing

Pharmaceutical manufacturing FDA Manufacturing Pharmaceutical

FDA slams Intas, Ipca over manufacturing shortfalls at 3 Indian plants

Fierce Pharma

JULY 7, 2023

After a pandemic-fueled lull the past few years, FDA inspections are back in full force. The FDA has issued a trio of Form 483s after inspecting three Indian drug plants. One write-up went to Intas Pharmaceuticals while the other two were handed down to Ipca Laboratories.

FDA

FDA Manufacturing Pharmaceutical

FDA grants approval to Regeneron Pharmaceuticals’ EYLEA HD injection

Pharmaceutical Technology

AUGUST 21, 2023

The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.

Food and Drug Administration

Food and Drug Administration Pharmaceutical FDA Food

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

MedCity News

APRIL 29, 2024

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.

FDA

FDA Pharmaceutical Biopharma Pharma

With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

Fierce Pharma

DECEMBER 21, 2023

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. |

FDA

FDA Pharmaceutical Patients

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

MARCH 14, 2024

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

FDA

FDA Pharma Pharmaceutical Biopharma

Alvogen's bid to force FDA to approve generic to Bausch's Xifaxan shot down by federal court

Fierce Pharma

NOVEMBER 3, 2023

Bausch Health’s gastroenterology unit Salix Pharmaceuticals has chalked up a win in its long-running fight to fend off a generic to its irritable bowel syndrome diarrhea (IBD-D) med Xifaxan. | federal court denied Alvogen's bid to force the FDA to grant full approval to its proposed Xifaxan generic.

FDA

FDA Pharmaceutical

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

FDA

FDA Medical Pharmaceutical Biopharma

Citius' $40M bid to market a follow-up to Eisai's Ontak hits wall at FDA

Fierce Pharma

JULY 31, 2023

Citius Pharmaceuticals’ $40 million bet on a Dr. Reddy’s drug to replace the withdrawn cancer med Ontak has hit a snag in the U.S. Citius' application for Lymphir (denileukin diftitox) in relapsed or refractory cutaneous T-cell lymphoma (CTCL) has been rejected by the FDA.

FDA

FDA Marketing Pharmaceutical

FDA rebuffs Amneal's Parkinson's prospect with $500M peak sales target

Fierce Pharma

JULY 5, 2023

Amneal Pharmaceuticals’ hopes for a midyear launch of its extended-release Parkinson’s disease prospect—and a shot at a potential $500 million peak sales opportunity in the U.S.—have

Prospecting

Prospecting Sales FDA Pharmaceutical

Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

MARCH 11, 2024

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”

Pharmaceutical

Pharmaceutical Food and Drug Administration Manufacturing Pharmaceutical products

Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

MedCity News

JANUARY 16, 2024

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease.

FDA

FDA Pharmaceutical Leads Biopharma

Eton Pharma hit with FDA rejection for methanol poison treatment as regulator flags manufacturing concerns

Fierce Pharma

JUNE 28, 2023

Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.” | The dehydrated alcohol injection was turned down due to problems with its chemistry manufacturing and controls, issues which the company believes are addressable, (..)

Manufacturing

Manufacturing FDA Pharma Pharmaceutical

FDA accepts Vanda Pharmaceuticals’ NDA for gastroparesis treatment

Pharmaceutical Technology

DECEMBER 5, 2023

The US FDA has accepted the NDA filed by Vanda Pharmaceuticals for its drug tradipitant to treat gastroparesis symptoms.

Pharmaceutical

Pharmaceutical FDA

Vanda turns back on hostile takeover bid by CDMO Future Pak

Fierce Pharma

APRIL 18, 2024

Two weeks after gaining a hard-earned FDA label expansion for its long-established antipsychotic drug Fanapt (iloperidone), Vanda Pharmaceuticals has derailed a hostile takeover bid. |

FDA

FDA Pharmaceutical

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

FDA

FDA Leads Pharmaceutical Patients

FDA warning letters highlight data integrity issues

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

FDA

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing

FDA approves Milla Pharmaceuticals’ generic version of Precedex

Pharmaceutical Technology

JUNE 12, 2023

The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL. Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list.

Food and Drug Administration

Food and Drug Administration Pharmaceutical FDA Food

In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

Fierce Pharma

MAY 9, 2024

It’s not an easy question to answer. While Vertex leads in patient starts, bluebird has activated more treatment centers.

Leads

Leads Patients FDA Pharmaceutical

FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

MedCity News

FEBRUARY 14, 2024

Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.

FDA

FDA Pharmaceutical Biopharma Pharma

Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical

Pharmaceutical Food and Drug Administration Medicine FDA

FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

PharmExec

MAY 6, 2024

Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.

FDA

FDA Pharmaceutical

US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

Food and Drug Administration

Food and Drug Administration Pharmaceutical FDA Side effects

ARS Pharmaceuticals hit with surprise FDA rejection of Neffy, its nasal spray epinephrine alternative

House lawmaker brings FDA into biosecurity crackdown on China

Trending Sources

Vanda secures FDA approval for Fanapt to treat bipolar I, 15 years after schizophrenia nod

Vertex, CRISPR's gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

FDA rejects Defender Pharma's motion sickness nasal gel candidate

FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

X4 enters commercial fold with FDA approval of rare disease drug Xolremdi

5 years after initial FDA rejection, Lexicon prepares to resubmit Type 1 diabetes hopeful Zynquista

After buying Novan's assets, Ligand crosses FDA finish line with molluscum gel Zelsuvmi

After Formosa snags FDA nod for reformulation of old steroid, partner Eyenovia plots launch

Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback

FDA approves X4 Pharmaceuticals’ WHIM syndrome drug

Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat

After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma

Look out, Teva. Neurocrine's Ingrezza wins Huntington's disease FDA nod to rival Austedo

Jazz brings the noise to the FDA with lawsuit over approval of Avadel's narcolepsy drug Lumryx

FDA clears Tarsus' Xdemvy as first treatment for common eyelid disease

Intas analyst poured acid over manufacturing docs, FDA says in scathing warning letter

US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing

FDA slams Intas, Ipca over manufacturing shortfalls at 3 Indian plants

FDA grants approval to Regeneron Pharmaceuticals’ EYLEA HD injection

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

Alvogen's bid to force FDA to approve generic to Bausch's Xifaxan shot down by federal court

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

Citius' $40M bid to market a follow-up to Eisai's Ontak hits wall at FDA

FDA rebuffs Amneal's Parkinson's prospect with $500M peak sales target

Preventing fungal contamination in pharmaceuticals

Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

Eton Pharma hit with FDA rejection for methanol poison treatment as regulator flags manufacturing concerns

FDA accepts Vanda Pharmaceuticals’ NDA for gastroparesis treatment

Vanda turns back on hostile takeover bid by CDMO Future Pak

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

FDA warning letters highlight data integrity issues

FDA approves Milla Pharmaceuticals’ generic version of Precedex

In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

Pharmaceutical industry: 2023 in retrospect

FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy

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