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Sun Pharma Advanced Research zooms 20% on huge volumes; details here

Till 01:44 PM; as many as a combined 27.7 million equity shares representing 8.5 per cent of the total equity of pharmaceutical company have changed hands on the NSE and BSE.

Wockhardt soars 19% on huge volumes; here's why the pharma stock rose today

The company said the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its first-in-class antibiotic 'Zaynich'

Lupin gets US FDA nod for its first biosimilar drug Pegfilgrastim

The product, a biosimilar to Amgen's popular drug Neulasta, will be manufactured at Lupin's biotech facility in Pune

Zydus gets USFDA's orphan drug designation for beta-thalassemia product

Zydus Lifesciences on Thursday said the US health regulator has granted Orphan Drug Designation (ODD) to Desidustat, a novel product for the treatment of beta-thalassemia. The US Food and Drug Administration (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop Desidustat to address beta-thalassemia," Zydus Lifesciences MD Sharvil Patel said in a regulatory filing. Beta thalassaemia patients have low levels of haemoglobin, which results in a lack of oxygen in many parts of the body, leading to weakness, fatigue and more serious complications. Treatment for people with beta thalassaemia often requires lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) an

FDA's top drug regulator resigns after officials probe 'serious concerns'

The head of the Food and Drug Administration's drug centre abruptly resigned on Sunday after federal officials began reviewing serious concerns about his personal conduct, according to a government spokesperson. Dr George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services' Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned on Sunday morning. Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency, Hilliard said. The departure came the same day that a drugmaker connected to one of Tidmarsh's former business associates filed a lawsuit alleging that he made false and defamatory statements during his time at the FDA. The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a longstand

Glenmark recalls product in US over manufacturing issue: USFDA

Drugmakers Glenmark and Dr Reddy's Laboratories are recalling products in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator noted that a US-based unit of Glenmark Pharmaceuticals is recalling 26,928 packs of oral contraceptive medication in the US. Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Viorele, Desogestrel and Ethinyl Estradiol (USP, 0.15 mg/ 0.02 mg) and Ethinyl Estradiol tablets due to "failed impurities/degradation specifications." The affected lot was produced at Mumbai-headquartered drug maker's Goa manufacturing facility. The drug firm issued the Class II nationwide recall on September 3, 2025. USFDA stated that a US-based subsidiary of Dr Reddy's Laboratories is recalling the medication used to provide muscle relaxation during surgery. Princeton, New Jersey-based Dr. Reddy's Laboratories, Inc is recalling 571 vials o

Dr Reddy's, Zydus recall products in US over manufacturing issues: USFDA

Drug majors Dr Reddy's Laboratories and Zydus Lifesciences are recalling products in the US for manufacturing issues, according to the US health regulator. In its latest Enforcement Report, US Food and Drug Administration (USFDA) stated that an American subsidiary of the Hyderabad-based drug major is recalling 571 vials of an injection used to relax muscles. Princeton-based Dr Reddy's Laboratories, Inc is recalling the affected lot of Succinylcholine Chloride Injection due to "Out-of-Specification result during the six-month stability testing," the USFDA stated. The company initiated the nationwide (US) Class II recall on September 26 this year. The USFDA stated that US-based arm of Zydus Lifesciences is recalling over 1,500 boxes of an antiviral medication used primarily to treat chronic hepatitis B virus. Pennington, New Jersey-based Zydus Pharmaceuticals (USA) Inc is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg respectively due to "failed .

Biocon gets USFDA's tentative approval for antibacterial drug Rifaximin

The USFDA's tentative approval means Biocon Pharma's Rifaximin 550 mg meets regulatory requirements but cannot be marketed in the US yet due to patents or exclusivity on the original drug

Wockhardt files new drug application with USFDA for antibacterial drug

Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing. The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR), it added. In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated. "This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation," Wockhardt Ltd said. The NDA submission follows

Trump to launch 'TrumpRx', to make drugs cheaper for Americans, says report

After talks with US President Donald Trump, global pharma giant Pfizer is further expected to announce a $70 billion investment in research, development and domestic manufacturing

Glenmark, Zydus recall products in US over manufacturing issues: USFDA

Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA). The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report. A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to "CGMP deviations" following market complaints received for gritty texture, USFDA said. New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. Hyderabad-based Granules India is recalling over 49,000

USFDA cautions doctors on acetaminophen use in pregnancy, cites risks

The US drug regulator flagged concerns over acetaminophen use in pregnancy, citing studies linking it to autism and ADHD, while noting no proven causal relationship

Indian pharma faces US revenue slowdown amid scrutiny, tariffs: ICRA

ICRA projects Indian pharma firms' US revenue growth to slow due to price erosion, USFDA scrutiny and tariff risks, while high dependence on Chinese APIs persists despite PLI

Natco Pharma surges 5% after USFDA classifies Hyderabad facility as VAI

Natco Pharma stock was trading at ₹884.5, up 3.2 per cent compared to the previous session's close of ₹857.25 on the NSE

Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

Pharma in bitter health: Stocks sink upto 38% in 2025; time to bottom fish?

Among stocks, Natco Pharma plunged 37.85%, Ipca Labs 22.43%, Aurobindo Pharma 17.99%, and Sun Pharma 14.30%. Other laggards include Lupin (13.25%), and Dr Reddy's (5.17%).

Caplin Point's unit gets USFDA nod for generic milrinone lactate injection

Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) milrinone lactate in 5 per cent Dextrose Injection of strengths 20 mg/100 mL and 40 mg/200 mL in single-dose infusion bags, Caplin Point Laboratories said in a regulatory filing. The approved injection is a generic therapeutic equivalent version of the reference listed drug PRIMACOR in dextrose 5 per cent, by Sanofi Aventis US LLC, it added. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, the company said. Citing IQVIA (IMS Health) data, the company said milrinone lactate in 5 per cent ...

Lupin share price rises 3% as USFDA okays schizophrenia drug; details

Drugmaker Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension

Sun Pharma slips 5% in 2 days, nears 52-wk low; why drug stock trades weak?

Thus far in August 2025, Sun Pharma has underperformed the market by falling 8 per cent, as compared to a 1 per cent decline in the BSE Sensex

US pharma tariffs unlikely to hit Indian drugmakers materially: Ind-Ra

Ind-Ra said US tariffs may cause only short-term pricing impact for Indian pharma as firms remain fortified by diversification, strong balance sheets, and global market positioning