Page 3 of USFDA

Recap 2023, year-ender 2023, drug approvals, USFDA, USFDA approvals, healthcare news, pharma news,

Recap 2023: From postpartum depression to Alzheimer’s disease, here are some crucial USFDA approvals this year

From Alzheimer’s disease and cancer to migraines, menopausal symptoms and post-partum depression, these approved drugs cater to a wide range…

December 26, 2023 13:41 IST

Lupin, Lupin Limited, USFDA, contraceptive drugs, pregnancy pills, healthcare news, pharma news,

USFDA gives nod to Lupin’s contraceptive drug

Norgestrel and Ethinyl Estradiol Tablets USP had estimated annual sales of USD 33 million in the U.S. (IQVIA MAT October…

December 1, 2023 16:45 IST

Lupin, Lupin Limited, generic formulations, sleep disorders, healthcare news,

USFDA grants tentative approval to Lupin’s generic drug for Type 2 Diabetes

This product will be manufactured at Lupin’s Pithampur facility in India.

November 22, 2023 08:26 IST

Strides Pharma, Strides Pharma Science, USFDA, USFDA approvals, healthcare news, pharma news,

USFDA gives nod to Strides Pharma’s generic drug for seizures

As per IQVIA data, the Levetiracetam Oral Solution has a market size of USD 55 million.

November 21, 2023 13:28 IST

Lupin gets USFDA approval for injection indicated for controlled ovarian hyperstimulation

The product will be manufactured at Lupin’s Nagpur facility in India.

November 20, 2023 09:00 IST

USFDA, orphan drugs, healthcare news, pharma news,

FDA’s orphan drug designations increase for myelofibrosis drugs, reveals GlobalData

This recombinant fusion protein was awarded ODD by the FDA in January 2020 and is currently in Phase III for…

November 20, 2023 07:00 IST

USFDA, Chikungunya vaccine, drug approval, healthcare news, pharma news,

World’s first Chikungunya vaccine gets USFDA nod; Approval granted for 18 years and above

The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas…

November 10, 2023 16:19 IST

USFDA, Rare blood disorder, replacement therapy, healthcare news, pharma news,

USFDA gives nod to world’s first enzyme replacement therapy for patients with rare blood clotting disorder

Symptoms of this rare disorder typically develop in infancy or early childhood, but in some cases may develop in adulthood…

November 10, 2023 15:45 IST

Lupin, Lupin Limited, USFDA, generic formulation, healthcare news, pharma news,

USFDA gives nod to Lupin’s generic muscle relaxant formulation in United States

Rocuronium Bromide Injection (RLD: Zemuron) had estimated annual sales of USD 54 million in the U.S. (IQVIA MAT August 2023).

November 9, 2023 13:42 IST

Suven Pharma, Suven Pharma Q2 results, profit, revenue, EBITDA, margins, inventory destocking, cash flow, CDMO business, Specialty Chemical, formulation, appointment, management team

USFDA approves Eli Lilly’s new drug for chronic weight management

It is unknown whether Zepbound causes such tumors, including medullary thyroid cancer, in humans.

November 9, 2023 13:06 IST

Lupin gets EIR from USFDA for its Mandideep Unit-2 manufacturing facility

The inspection closed with the facility receiving an inspection classification of “No Action Indicate” (NAI).

November 1, 2023 15:31 IST

Amgen, Biosimilars, Inflammatory diseases, USFDA, USFDA news, healthcare news, pharma news,

USFDA approves Amgen’s biosimilar for multiple inflammatory diseases

Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks, USFDA stated.

November 1, 2023 13:23 IST

activist, anemia, healthcare news, wellness news, drugs,

FDA staff raises concerns over lack of safety data for Sickle-Cell treatment

In the experimental procedure, the companies remove blood stem cells, edit them in a lab using Crispr and then infuse…

October 30, 2023 09:00 IST

Novo Nordisk, GLP1, pharma sales, healthcare news, pharma news,

USFDA gives approval to Granules India for its delayed-release capsule to treat GERD symptoms

The current annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 Million, according to MAT Jul 2023, IQVIA/IMS…

October 19, 2023 14:31 IST

Glenmark Pharma, Glenmark Pharma Q2 results, profit, loss, revenue, EBITDA, legal settlement, expenses, branded formulations, domestic business

USFDA gives final nod to Glenmark’s psoriasis drug

It is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.

October 17, 2023 12:25 IST

USFDA gives tentative approval to Lupin’s prostate cancer tablets

This product will be manufactured at Lupin’s Pithampur facility in India.

October 17, 2023 11:22 IST

USFDA gets tentative approval for tablets to treat low sodium levels in heart patients

This product will be manufactured at Lupin’s Nagpur facility in India.

October 6, 2023 11:18 IST

cough syrup, cough syrup deaths, healthcare news, pharma news,

US cracks down on toxic drug testing after cough syrup-linked deaths globally

In the United States, more than 100 people, most of them children, died in the 1930s from DEG poisoning, prompting…

September 27, 2023 14:10 IST

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‘Private credit won’t replace bank credit, ‘ says Kanchan Jain

Banking & Finance1 hr ago

Ascertis Credit has successfully raised $520 million in the first close of Fund IV, with a target of $1 billion by next year. Head of the group, Kanchan Jain, discusses the growth of India’s private credit market and the fund’s plans. While the RBI’s allowance for banks to do acquisition financing may not impact private credit funds, experienced credit managers are needed for large transactions.

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