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The Latest Breaking News from USFDA

Lupin gets USFDA approval for Modafinil tablets to treat excessive sleepiness

Pharmaceutical major Lupin announced its USFDA approval for Modafinil tablets. These tablets are used to treat excessive sleepiness in adult patients. The approved drug is bioequivalent to Provigil Tablets of Nuvo Pharmaceuticals. Modafinil tablets had estimated annual sales of USD 70.7 million in the United States. Lupin currently operates 15…

The Economic Times

Block deal alert! Gland Pharma shares fall 3% as 1.2 crore shares change hands in 2 block deals; promoter Fosun likely seller

Gland Pharma shares fell after a significant block deal involving Fosun Pharma Industrial. The company's VSEZ facility received zero USFDA observations after a recent inspection. Gland Pharma reported strong Q1FY27 results with increased profit and revenue. Its CDMO and B2B businesses showed substantial year-on-year growth. The pharma stock has gained…

The Economic Times

Stocks in news: Groww, Tata Motors PV, Cipla, Varun Beverages and Axis Bank

The Indian equity market experienced a positive turnaround on Tuesday, August 25, highlighted by the Nifty 50 making a robust recovery. Anticipation builds for Wednesday as Groww gears up for a significant block deal, while Cipla faces new USFDA inspectional observations. In other news, Tata Motors Passenger Vehicles is set…

The Economic Times

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Zydus Lifesciences gets USFDA nod for generic ascorbic acid injection

Zydus Lifesciences secured final USFDA approval for its generic ascorbic acid injection. This approval is for the treatment of scurvy in specific patient groups. The company's product is the generic equivalent of the Ascor injection. The USFDA designated this application as a Competitive Generic Therapy. Zydus will market the product…

The Economic Times

Strides Pharma Science shares jump 9% after USFDA EIR for Bengaluru facility

Strides Pharma Science shares rise sharply on Thursday after the USFDA issued an Establishment Inspection Report (EIR) for its Bengaluru facility, concluding a recent cGMP inspection. The inspection ended with five observations, which the company addressed through corrective actions. The regulatory closure offers relief after the stock’s recent weakness.

The Economic Times

Lupin shares in focus after USFDA nod for drug to treat excessive daytime sleepiness

Lupin received USFDA approval for generic Pitolisant Tablets, strengthening its US portfolio and specialty generics presence. Shares remain technically weak despite strong long-term returns, with FIIs raising their stake while mutual fund holdings declined. The stock trades below most key moving averages, keeping near-term momentum subdued despite the positive regulatory…

The Economic Times

Glenmark gets USFDA nod for expanded use of RYALTRIS nasal spray

Glenmark Pharmaceuticals announced US FDA approval for RYALTRIS nasal spray. This approval expands its use to children aged six to twelve years. The nasal spray treats symptoms of seasonal allergic rhinitis effectively. RYALTRIS combines antihistamine and corticosteroid in one formulation. This marks a significant step in expanding access to the…

The Economic Times

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Alembic Pharma partner NATCO gets USFDA tentative nod for generic Olaparib tablets; US market size at USD 1.4 bn

Alembic Pharmaceuticals and NATCO Pharma received tentative USFDA approval for generic Olaparib tablets. This approval is for a cancer drug, which is a generic equivalent of Lynparza. Alembic will distribute the product while NATCO Pharma will manufacture the tablets. The product addresses a significant market opportunity, estimated at USD 1.4…

The Economic Times

Alembic Pharma gets USFDA nod for generic influenza treatment drug

Alembic Pharmaceuticals has secured USFDA approval for its generic oseltamivir phosphate oral suspension, a key treatment for influenza. This development offers a more accessible option for patients aged two weeks and above suffering from acute, uncomplicated flu. The approval marks a significant step in providing affordable alternatives to the reference…

The Economic Times

Alembic Pharma gets tentative nod from USFDA for generic cancer drug

Alembic Pharmaceuticals has secured tentative approval from the USFDA for its generic Binimetinib tablets. This marks a significant step for the company in the cancer treatment drug market. The approval is for the 45mg strength, with potential for marketing exclusivity. Alembic previously received tentative approval for the 15mg strength. Binimetinib…

The Economic Times

USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observations

Jubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washington, received eight observations. These observations do not involve sterility assurance concerns. The company will submit its response to the US health regulator within 15 business days. Jubilant Pharmova is committed to addressing…

The Economic Times

HPV vaccine rollout faces wild theories and real questions. The govt is unready for both

The recent launch of a nationwide vaccination programme aimed at preventing cervical cancer in teenage girls and women has been met with scepticism and doomsday predictions by a section of very vocal critics of vaccination on social media.

Newslaundry

7 Things That Will Get Cheaper After Budget 2026

Most budgets promise relief. Very few actually change what you pay in real life. Budget 2026 is one of those rare ones that works quietly. There were no dramatic tax cuts, no loud announcements, and no instant price drops flashed across screens. Yet, beneath the fine print, the government made…

Times Life

Further cat food recalled amid bird flu concerns with more cats falling ill

The US Food and Drug Administration has recalled a further four products

PetsRadar

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The Times of India

Non-nutritive sweeteners: A safe tool to reduce sugar, calories among different consumer age groups

Non-nutritive sweeteners (NNS), also known as low and no-calorie sweeteners (LNCS), are alternatives that contain zero or very low amounts of carbohydrates or energy. These sweeteners can act as an effective tool to reduce caloric content and sugar, which when consumed in excess and without proper diet or exercise, can…

The Hindu

Realty developer Aparna Group forays into pharmaceuticals business

The United States Food and Drug Administration had audited the facility in September 2023.

The Hindu

India, U.S. discuss ways to boost trade, investments ties at TPF meet

New Delhi and the U.S. discuss trade and investment ties, addressing issues such as social security and market access.

Bangkok Post

Leader of the most comprehensive non-surgical laser hair transplantation centre

“The centre of the most exclusive technique to increase the thickness and number of hairs without surgery. The Comprehensive solutions to all hair loss and thinning hair in one place”

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The Guardian - UK

India must act on drug adulteration – lives around the world are at stake

Cases of disregard for manufacturing standards are risking the country’s reputation as the ‘developing world’s pharmacy’

The Hindu

Zenara Pharma gets CDSCO nod to make copy of Pfizer’s Paxlovid

Combi pack of Nirmatrelvir, Ritonavir tablets is for patients with moderate symptoms of Covid-19

The Times of India

Hyderabad-based Zenara Pharma gets CDSCO nod to manufacture generic version of Pfizer's Covid-19 pill

HYDERABAD: Hyderabad-based Zenara Pharma, a fully-owned subsidiary of Biophore India Pharmaceuticals, on Thursday said it has received emergency use authorisation (EUA) from the Central Drugs Standard Control Organization (CDSCO) to manufacture and market in India a generic version of Pfizer’s Covid-19 pill Paxlovid for the treatment of patients with mild…

The Times of India

US Food and Drug Administration lifts clinical hold, Covaxin trials to resume

HYDERABAD: The US Food and Drug Administration (USFDA) has lifted the clinical hold on the Phase 2 and 3 immuno-bridging clinical trials of Bharat Biotech’s Covid-19 vaccine, Covaxin, in the US.

The Hindu

Morning Digest | Four militants behind J&K targeted killings shot dead; Covaxin trials in U.S. put on hold, and more

A select list of stories to read before you start your day

Newslaundry

The Bedaquiline Question

One of the increasingly contentious public health issues in India is the manner in which clinical trials are conducted for new drugs and the manner in which these new drugs are subsequently approved for use on Indian patients.

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