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  3. usfda

USFDA

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US tariff & reshoring: Indian pharma debates impact of 3x rise in US drug-making costs
US tariff & reshoring: Indian pharma debates impact of 3x rise in US drug-making costs 

Since higher cost of operations is a major deterrent at the moment, Indian pharma companies see the likely implications in…

Updated: July 22, 2026 13:15 IST
Jubilant Pharmova's Pantoprazole oral suspension receives USFDA tentative approval
Jubilant Pharmova gets tentative USFDA nod for Pantoprazole oral suspension

Jubilant Pharmova expects final approval from the USFDA for its Pantoprazole oral suspension after the patent expires in 2026. Read…

June 26, 2026 12:45 IST
Wockhardt’s USFDA Nod for Zaynich: Inside a 20-Year, $800 Million Gamble on Antibiotic Innovation
Newspoint: Khorakiwala’s antibiotic bet

The USFDA approval of Zaynich caps a high-risk journey in antibiotic research

June 5, 2026 21:22 IST
Not Cipla, Not Lupin: 2 high-ROCE pharma ‘compounders’ with non-stop quarterly profit growth

While Nifty Pharma giants struggle with regulatory headwinds and pricing pressures, two outliers are quietly catching the attention of smart…

March 10, 2026 05:24 IST
FDA Indian origin Dr Vinay Prasad
Who is Dr Vinay Prasad? Trump admin’s controversial Indian-origin FDA vaccine chief exits again

Dr Vinayak (Vinay) Kashyap Prasad, who served as both the agency’s Chief Medical and Scientific Officer and as the Director…

March 7, 2026 18:54 IST
Gujarat govt favouring US firms with differential pricing for stents, AiMeD writes to Nadda
Gujarat govt favouring US firms with differential pricing for stents, AiMeD writes to Nadda

Aimed has also sought Nadda’s “urgent intervention” and “roll back the unfair discriminatory notification”.

April 2, 2025 12:11 IST
USFDA gives nod to first generics of Xarelto to treat stroke and heart disorders
USFDA grants marketing authorisation of first home test for sexually transmitted infections

The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk…

March 30, 2025 10:55 IST
USFDA gives nod to first generics of Xarelto to treat stroke and heart disorders
FDA gives nod to first generics of Xarelto to treat stroke and heart disorders

The approval is only for the 2.5mg tablet. Xarelto is also available in 10mg, 15mg, and 20mg tablets, as well…

March 11, 2025 11:23 IST
USFDA, Granola bars, granola bar risk, USFDA alerts, metal contamination, USFDA news, healthcare news, pharma news,
FDA Alert: Millions of granola bars recalled over metal contamination; Classified as class II risk

Certain batches of MadeGood granola bars were recalled due to the potential presence of a piece of metal in the…

February 18, 2025 10:33 IST
FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment
FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment

To date, the FDA has approved 65 biosimilar products for a variety of health conditions.

February 15, 2025 12:49 IST
USFDA, Ozempic, Ozempic news, Novo Nordisk, Novo Nordisk news, USFDA news, healthcare news, pharma news,
USFDA gives nod to Novo Nordisk’s Ozempic to reduce risk of kidney failure

Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the…

January 29, 2025 10:11 IST
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USFDA issues warning of serious allergic reaction with multiple sclerosis drugs; Urges patients to be cautious

Patients should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 911…

January 23, 2025 12:31 IST
USFDA issues warning against use of anti-allergic nasal spray intravenously
USFDA issues warning against use of anti-allergic nasal spray intravenously

Recently in 2024, the agency received a report involving a patient who received the nasal solution as an injection.

January 17, 2025 12:50 IST
USFDA gives nod to Alembic Pharma's genetic formulation to treat heart failure
USFDA gives nod to Alembic Pharma’s genetic formulation to treat heart failure

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending…

November 12, 2024 16:44 IST
USFDA, Decongestant, Decongestant usage, phenylephrine, phenylephrine side effects, USFDA news, healthcare news, pharma news,
USFDA proposes removal of common decongestant from shelves after finding it ineffective

The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from…

November 8, 2024 12:44 IST
USFDA gives nod to Alembic Pharma's generic formulation to treat heart disorder
USFDA gives nod to Alembic Pharma’s generic formulation to treat heart disorder

Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg have an estimated market size of US$ 28.2…

October 21, 2024 11:25 IST
USFDA gives nod to Pfizer's drug therapy for patients with Hemophilia
USFDA gives nod to Pfizer’s drug therapy for patients with Hemophilia

The FDA granted Hympavzi Orphan Drug designation for this application.

October 14, 2024 11:34 IST
USFDA gives nod to first over-the-counter home Flu and COVID-19 combination test
USFDA gives nod to first over-the-counter home Flu and COVID-19 combination test

According to USFDA, as with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a…

October 8, 2024 16:55 IST
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Sensex, Nifty today: GIFT Nifty signals cautious start as Brent continues near $97
Sensex, Nifty today: GIFT Nifty signals cautious start as Brent continues near $97
Market

Asian markets show mixed trading, GIFT Nifty down 0.07%, Brent crude above $97 a barrel. Indian equity benchmarks fell 0.50% on Monday. Key cues for September 8, 2026 include global and domestic market performance, US stock market holiday, US futures pressure, crude oil prices, gold and silver rates, FII and DII data, and US dollar index.

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