Page 4 of USFDA

Viatris, HIV drugs, USFDA, USFDA approval, healthcare news, pharma news,

Viatris gets USFDA’s tentative approval of its HIV drug for children

The World Health Organization (WHO) recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for paediatric patients.

September 5, 2023 16:36 IST

healthcare revolution, health news, pharma news,

FDA Warns on contamination response at infant formula plants

Last year, a nationwide shortage of infant formula occurred after cronobacter was discovered at an Abbott Laboratories facility.

September 1, 2023 08:00 IST

USFDA, drug approvals, Pfizer, RSV, RSV in infants, healthcare news, pharma news,

USFDA approves Pfizer’s vaccine for mothers to prevent RSV in infants

Moreover, the USFDA has asked the company to conduct postmarketing studies to assess the signal of serious risk of preterm…

August 22, 2023 14:10 IST

USFDA, RSV drug, Sanofi, AstraZeneca, healthcare news, pharma news,

USFDA approves Sanofi and AstraZeneca’s drug to prevent RSV in babies and toddlers

In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus.

July 18, 2023 12:38 IST

Antibiotic resistance, Antimicrobial resistance, AMR, ICMR, healthcare news,

FDA allows more cancer drug imports from China as US faces shortages

For some cancer centers, the availability of cisplatin and other generic cancer drugs is improving.

July 11, 2023 11:30 IST

Alembic Pharmaceuticals gets 5 USFDA approvals in Q1FY24

Alembic has received a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from the US…

July 3, 2023 14:32 IST

Strengthening trust, transparency & talent key to better quality medicines: IPA

The Indian Pharmaceutical Alliance, a platform of leading Indian pharma companies, is seeing hope with government, regulators and industry aligning…

Updated: June 27, 2023 12:57 IST

Dr Reddy’s Laboratories, Q2FY24 results, pharmaceutical, revenue, profit, EBITDA, capital expenditure, R&D investments, cash flow, Generics business, new products, Pharmaceutical Services and Active ingredients, price erosion

USFDA closes inspection at Dr Reddy’s API plant

The inspection was conducted from June 12 to 16, 2023, and closed with zero observations.

June 18, 2023 04:30 IST

Lupin, Lupin Limited, USFDA, generic drugs, health news, pharma news,

USFDA gives final nod to Lupin’s seizure tablets

The drug works by decreasing abnormal electrical activity in the brain.

December 21, 2022 14:01 IST

USFDA approves Alembic Pharmaceuticals’ arthritis drug

The medication is used to relieve joint pain from arthritis and it comes under nonsteroidal anti-inflammatory drugs (NSAIDs).

December 1, 2022 13:03 IST

Spectrum Pharmaceuticals, USFDA, lung cancer drug, poziotinib, Luye Pharma, health news, pharma news,

USFDA declines to approve Spectrum Pharmaceuticals’ lung cancer drug

Poziotinib is a drug developed by Hanmi Pharmaceutical, Luye Pharma, and Spectrum Pharmaceuticals for various cancers.

November 25, 2022 18:30 IST

USFDA gives final nod to Alembic Pharmaceuticals’ chemotherapy capsules

Cyclophosphamide Capsules are a medication used as chemotherapy and to suppress the immune system.

November 14, 2022 11:11 IST

AstraZeneca, AstraZeneca pharma, Cardiac care, heart diseases, chemotherapy, health news, pharma news,

Alembic Pharma receives final approval from USFDA for generic Mesalamine extended-release capsules

The approval granted by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Mesalamine…

Updated: November 2, 2022 11:24 IST

USFDA, Mallinckrodt, terlipressin, hepatorenal syndrome, health news, pharma news,

USFDA approves Mallinckrodt’s injection to treat serious kidney and liver condition

Hepatorenal syndrome (HRS) is an acute and life-threatening condition that involves a rapid reduction in kidney function and occurs in…

September 16, 2022 12:27 IST

Abbott, USFDA, Heart Valve Repair Device, USFDA, Health news, pharma news,

Abbott’s heart valve repair device has potential clip lock issue, USFDA warns

The FDA said the malfunctions appear to occur in about 1.3 percent of MitraClip procedures and have been observed with…

September 9, 2022 14:52 IST

Cancer, cancer research, cancer treatment, breast cancer, anaesthesia, Tata memorial centre, health news,

Breast implants can cause cancer? USFDA receives several reports

The U.S. Food and Drug Administration (USFDA) on Thursday said that it has received several reports of certain types of…

September 9, 2022 13:05 IST

USFDA, Emergent BioSolutions Inc, Healthcare, healthcare news,

USFDA issues warning to Emergent over quality control issues

The FDA pointed to deficiencies in cleaning and maintenance of equipment to prevent contamination of drug products and also recommended…

August 15, 2022 17:50 IST

Sun Pharma, Glenmark, USFDA, health news, pharma news,

Sun Pharma, Glenmark recall products due to manufacturing issues in United States

Reportedly, the Mumbai-based drug major is recalling the affected lot due to “water leakage” leading to deviation from current good…

July 25, 2022 18:08 IST

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